相关申请的交叉引用Cross References to Related Applications
本申请是于2011年2月8日提交的标题为“便携式透析机”的共同未决的美国专利申请第13/023490号(以下简称“′490申请”)的部分继续申请。This application is a continuation-in-part of co-pending US Patent Application Serial No. 13/023,490, filed February 8, 2011, and entitled "Portable Dialysis Machine" (hereinafter "the '490 application").
′490申请是于2008年9月25日提交的美国专利申请第12/237914号的部分继续申请，其优先权依赖于于2007年9月25日提交的美国专利临时申请第60/975157号。The '490 application is a continuation-in-part of US Patent Application Serial No. 12/237914, filed September 25, 2008, with priority dependent on US Patent Provisional Application Serial No. 60/975,157, filed September 25, 2007.
′490申请是于2009年10月30日提交的美国专利申请第12/610032号的部分继续申请，其优先权依赖于于2008年10月30日提交的美国专利临时申请第6l/109834号。The '490 application is a continuation-in-part of US Patent Application Serial No. 12/610032, filed October 30, 2009, with priority dependent on US Patent Provisional Application Serial No. 61/109834, filed October 30, 2008.
′490申请是美国专利申请第12/324924号的部分继续申请，其优先权依赖于于2007年11月29日提交的名称为“SystemandMethodofChangingFluidicCircuitBetweenHemodialysisProtocolandHemofiltrationProtocol”的美国临时专利申请第60/990959号和于2008年1月18日提交的具有相同名称的美国临时专利申请第61/021962号。The '490 application is a continuation-in-part of U.S. Patent Application No. 12/324924, and its priority depends on U.S. Provisional Patent Application No. 60/990959, entitled "System and Method of Changing Fluidic Circuit Between Hemodialysis Protocol and Hemofiltration Protocol," filed November 29, 2007 and filed in 2008 U.S. Provisional Patent Application No. 61/021962 of the same title, filed Jan. 18.
′490申请是美国专利申请第12/249090号的部分继续申请，其优先权依赖于于2007年10月11日提交的名称为“Photo-AcousticFlowMeter”的美国临时专利申请第60/979113号。The '490 application is a continuation-in-part of US Patent Application Serial No. 12/249090, which relies on priority to US Provisional Patent Application Serial No. 60/979113, filed October 11, 2007, entitled "Photo-Acoustic Flow Meter."
′490申请是美国专利申请第12/575449号的部分继续申请，其优先权依赖于于2008年10月7日提交的美国专利临时申请第6l/10327l号。The '490 application is a continuation-in-part of US Patent Application Serial No. 12/575449, which relies on priority from dependent US Patent Provisional Application Serial No. 61/103271, filed October 7, 2008.
′490申请是美国专利申请第12/75l930号的部分继续申请，其优先权依赖于于2009年3月31日提交的美国专利临时申请第6l/165389号。The '490 application is a continuation-in-part of U.S. Patent Application No. 12/751930, which relies on priority from U.S. Provisional Application No. 61/165389, filed March 31, 2009.
′490申请是美国专利申请第12/705054号的部分继续申请，其优先权依赖于于2009年2月12日提交的美国专利临时申请第61/151912号。The '490 application is a continuation-in-part of US Patent Application Serial No. 12/705054, which relies on priority to US Patent Provisional Application Serial No. 61/151912, filed February 12, 2009.
′490申请是美国专利申请第12/875888号的部分继续申请，其是美国专利申请第12/238055号的分案，美国专利申请第12/238055号的优先权依赖于于2007年9月28日提交的美国专利临时申请第60/975840号。The '490 application is a continuation-in-part of U.S. Patent Application No. 12/875,888, which is a division of U.S. Patent Application No. 12/238,055, the priority of which is reliant on September 28, 2007 U.S. Patent Provisional Application No. 60/975,840 filed on .
′490申请是美国专利申请第12/210080号的部分继续申请，其优先权依赖于于2007年9月13日提交的美国专利临时申请第60/971937号。The '490 application is a continuation-in-part of US Patent Application Serial No. 12/210080, the priority of which is dependent on US Patent Provisional Application Serial No. 60/971937, filed September 13, 2007.
′490申请是于2009年1月12日提交的美国专利申请第12/35l969号的部分继续申请。The '490 application is a continuation-in-part of US Patent Application Serial No. 12/351969, filed January 12, 2009.
′490申请是美国专利申请第12/713447号的部分继续申请，其优先权依赖于于2009年2月26日提交的美国专利临时申请第6l/155548号。The '490 application is a continuation-in-part of US Patent Application Serial No. 12/713447, which relies on priority to US Patent Provisional Application Serial No. 61/155548, filed February 26, 2009.
′490申请是美国专利申请第12/575450号的部分继续申请，其优先权依赖于于2008年10月7日提交的美国专利临时申请第6l/103274号。The '490 application is a continuation-in-part of US Patent Application Serial No. 12/575450, which relies on priority from US Patent Provisional Application Serial No. 61/103274, filed October 7, 2008.
上文列出的所有说明书的全部内容通过引用并入本文。All specifications listed above are hereby incorporated by reference in their entirety.
技术领域technical field
本发明涉及一种具有改进的结构特征和功能特征的便携式透析系统。特别地，本发明的透析系统涉及一种具有改进的模块性、易用性和安全性特征的便携式透析系统。The present invention relates to a portable dialysis system with improved structural and functional features. In particular, the dialysis system of the present invention relates to a portable dialysis system with improved modularity, ease of use and safety features.
背景技术Background technique
用于进行血液透析、血液透析滤过或血液滤过的血液净化系统涉及血液的经过具有半渗透膜的交换器的体外循环。这样的系统还包括用于循环血液的液压系统和用于循环置换液或透析液的液压系统，所述置换液或透析液包含浓度接近于健康的受试者的血液的浓度的某些血液电解质。然而，大多数常规可用的血液净化系统的尺寸非常庞大并且难以操作。此外，这些系统的设计使它们很笨重并且不利于一次性部件的使用和安装。Blood purification systems for performing hemodialysis, hemodiafiltration or hemofiltration involve extracorporeal circulation of blood through an exchanger with a semi-permeable membrane. Such systems also include a hydraulic system for circulating blood and a hydraulic system for circulating a replacement fluid or dialysate containing certain blood electrolytes in concentrations close to those of the blood of healthy subjects . However, most conventionally available blood purification systems are very bulky in size and difficult to operate. Furthermore, the design of these systems makes them bulky and does not facilitate the use and installation of disposable components.
使用医院中的固定设备的标准透析治疗，包括两个阶段，即(a)透析，其中有毒的物质和浮渣(通常为小分子)从血液经过半渗透膜至透析液体，以及(b)超滤，其中血液回路和透析液回路之间的压力差更精确地说是后者回路中的减压使血液的水含量被减少预确定的量。Standard dialysis treatment using stationary equipment in a hospital consists of two phases, namely (a) dialysis, in which toxic substances and scum (usually small molecules) pass from the blood through a semipermeable membrane to the dialysis fluid, and (b) ultrafiltration. Filtration in which the water content of the blood is reduced by a predetermined amount by the pressure difference between the blood circuit and the dialysate circuit, more precisely the decompression in the latter circuit.
使用标准设备的透析程序往往繁琐且成本很高，并且要求患者被长持续时间束缚于透析中心。虽然已经开发出了便携式透析系统，但是常规的便携式透析系统遭受某些缺点。首先，它们不足以模块化，由此防止易于对系统设定、移动、转运和维护。第二，系统未被简化地足以用于患者的可靠精确的使用。使用一次性部件的系统的接口和方法受到患者使用中的误用和/或错误。为了使便携式透析系统真正有效，其应当被不是健康护理专业人员的个人容易且方便地使用，其中一次性输入和数据输入被足够地约束成防止不精确的使用。Dialysis procedures using standard equipment are often cumbersome and costly, and require patients to be tethered to a dialysis center for long periods of time. Although portable dialysis systems have been developed, conventional portable dialysis systems suffer from certain disadvantages. First, they are not sufficiently modular, thereby preventing easy setup, movement, transport and maintenance of the system. Second, the system is not simplified enough for reliable and precise use by the patient. The interfaces and methods of systems using disposable components are subject to misuse and/or errors in patient use. In order for a portable dialysis system to be truly effective, it should be easy and convenient to use by individuals who are not health care professionals, with one-time entry and data entry sufficiently constrained to prevent imprecise use.
透析系统的一个常规设计使用单次通过系统。在单次通过系统中，透析液经过透析器中的血液一次并且然后被抛弃。单次通过系统具有源于使用大量水的多个缺点。首先，假设R.O.(反渗透)系统的50％排除率，则需要至少1000至1500ml/min的水。第二，需要用于提供已净化的水的100至800ml/分钟的连续流动的水净化系统。第三，需要至少15安培的电路，以便泵送100至800ml的水/分钟，以及第四，需要地面排水或任何其他的能够容纳至少1500ml/min的使用过的透析液和RO排除水的储液器。One conventional design of dialysis systems uses a single pass system. In a single-pass system, the dialysate passes once over the blood in the dialyzer and is then discarded. Single pass systems have several disadvantages stemming from the use of large amounts of water. First, assuming a 50% rejection rate of the R.O. (reverse osmosis) system, at least 1000 to 1500 ml/min of water is required. Second, a continuous flow water purification system for supplying 100 to 800 ml/min of purified water is required. Third, a circuit of at least 15 amps is required in order to pump 100 to 800ml/min of water, and fourth, a floor drain or any other reservoir capable of holding at least 1500ml/min of used dialysate and RO reject water is required liquid container.
常规系统也很不可靠，因为必须使用包括净化系统的流体回路的大量管子，从而增加泄漏和断裂的风险。除了因其尺寸较大而难以运输外，常规的透析机也苦于灵活性的缺乏。例如，基于吸附剂的血液透析程序具有很多特别的硬件要求，这些硬件没有被血液滤过工艺所共用。因此，将会有益的是，具有共用的硬件部件例如泵送系统，其可以用来使得透析系统可以在血液滤过模式和血液透析模式下工作。Conventional systems are also very unreliable, since a large number of tubes comprising the fluid circuit of the purge system must be used, increasing the risk of leaks and breakage. In addition to being difficult to transport due to their large size, conventional dialysis machines also suffer from a lack of flexibility. For example, sorbent-based hemodialysis procedures have many specific hardware requirements that are not shared by the hemofiltration process. Therefore, it would be beneficial to have common hardware components, such as pumping systems, that could be used to enable the dialysis system to operate in hemofiltration mode and hemodialysis mode.
此外，需要一种可以以安全、成本有效且可靠的方式有效地提供透析系统功能性的便携式系统。特别地，需要一种可以满足透析程序的流体递送要求同时在其中集成例如流体加热、流体测量和监视、泄漏探测和断开探测的各种其他关键功能的紧凑的透析流体储液器系统。Furthermore, there is a need for a portable system that can effectively provide the functionality of a dialysis system in a safe, cost-effective and reliable manner. In particular, there is a need for a compact dialysis fluid reservoir system that can meet the fluid delivery requirements of a dialysis procedure while integrating therein various other critical functions such as fluid heating, fluid measurement and monitoring, leak detection and disconnection detection.
特别地，就断开探测来说，对返回管线断开的有效探测是困难的，因为大多数的已知方法是基于监视和探测静脉返回线管路中的压力的改变。返回管线断开通常因针拔出状况而发生。因为针通常提供体外血液回路中的最高流体阻力，所以返回管线中的因针断开导致的压力变化不是很显著并且不能够被很容易地探测。压力降在其中导液管从患者的身体断开导致返回管线断开的情况下也是非常低的。因此，使用压力作为指示物或度量来探测返回静脉血液回路中的断开是不可靠的，并且可以导致严重的损伤。此外，不能够依赖使用空气泡的探测作为断开的指示的方法，因为在静脉返回管线中的断开不使空气被吸入返回管线管路。因此，需要一种改进的用于探测静脉返回管线中的断开的设备和方法。此外，还需要一种不需要任何额外元件比如放置在针插入部位处的防潮垫的设备和方法。In particular, with respect to disconnection detection, efficient detection of a return line disconnection is difficult since most known methods are based on monitoring and detecting pressure changes in the venous return line tubing. Return line disconnection usually occurs due to a needle withdrawal condition. Since needles generally provide the highest fluid resistance in an extracorporeal blood circuit, pressure changes in the return line due to needle disconnection are insignificant and cannot be easily detected. The pressure drop is also very low in situations where disconnection of the catheter from the patient's body results in a disconnection of the return line. Therefore, using pressure as an indicator or measure to detect breaks in the return venous blood circuit is unreliable and can result in serious injury. Furthermore, methods that use the detection of air bubbles as an indication of a disconnection cannot be relied upon because a disconnection in the venous return line does not allow air to be drawn into the return line line. Accordingly, there is a need for an improved apparatus and method for detecting a disconnection in a venous return line. Furthermore, there is a need for an apparatus and method that does not require any additional elements such as a moisture-proof pad placed at the needle insertion site.
此外，在现有技术中没有令人满意的用于在可以以合理的成本容易实施的透析过程期间保持体积精确度的机构。用于保持置换液和输出流体的体积精确度的现有技术方法的大多数不适用于与一次性装置使用。一种用于保持体积精确度的现有技术方法涉及称重置换液和输出流体二者。然而，这种方法在实践中难以实施。另一现有技术方法包括使用用于透析系统的体积平衡室。然而，这样的室在构建上既复杂且成本又高，并且也不适于一次性装置。体积流量测量是另一已知的方法，但是这种方法的精确度未被证明。此外，这种方法对于以一次性形式的透析系统来说非常难以实施。另一现有技术方法涉及使用两个活塞泵来实现体积精确度。然而，这种方法极端地难以以合理的成本以一次性形式实施，并且对于以所需要的泵送体积(200ml/min的数量级)操作来说也不经济。因此，需要一种可用于精确地保持被输注入患者且从其除去的流体的体积并且可以以低成本实施的方法和系统。Furthermore, there is no satisfactory mechanism in the prior art for maintaining volumetric accuracy during a dialysis procedure that can be easily implemented at reasonable cost. Most of the prior art methods for maintaining volumetric accuracy of replacement fluid and output fluid are not suitable for use with disposable devices. One prior art method for maintaining volumetric accuracy involves weighing both the replacement fluid and the output fluid. However, this approach is difficult to implement in practice. Another prior art approach involves the use of volume balance chambers for dialysis systems. However, such chambers are complex and costly to construct and are not suitable for disposable devices. Volumetric flow measurement is another known method, but the accuracy of this method has not been proven. Furthermore, this approach is very difficult to implement with dialysis systems in disposable form. Another prior art approach involves the use of two piston pumps to achieve volumetric precision. However, this approach is extremely difficult to implement in disposable form at reasonable cost, and is also not economical to operate with the required pump volumes (of the order of 200 ml/min). Accordingly, there is a need for a method and system that can be used to precisely maintain the volume of fluid being infused into and removed from a patient and that can be implemented at low cost.
此外，需要一种相对于常规系统降低总体水需求的多次通过的基于吸附剂的透析系统。还需要一种可用于单次通过的基于吸附剂的透析系统以及本发明的多次通过系统的歧管，其提供具有模制的血液和透析液流动路径的轻便结构来避免复杂网格的管路。Furthermore, there is a need for a multi-pass sorbent-based dialysis system that reduces overall water requirements relative to conventional systems. There is also a need for a single-pass sorbent-based dialysis system, as well as the multi-pass system manifold of the present invention, which provides a lightweight structure with molded blood and dialysate flow paths to avoid complex grids of tubing road.
还期望的是，具有一种具备配置成优化系统的模块性的结构设计的便携式透析系统，由此使得能够很容易地对系统设定、移动、转运和维护。进一步期望的是具有配置成防止在使用中出现错误且被足以约束来防止不精确使用的系统接口，患者通过其输入数据或部署一次性部件。It would also be desirable to have a portable dialysis system with a structural design configured to optimize the modularity of the system, thereby enabling easy setup, movement, transport and maintenance of the system. It is further desirable to have a system interface through which a patient enters data or deploys a disposable component that is configured to prevent errors in use and that is sufficiently constrained to prevent imprecise use.
发明内容Contents of the invention
在一个实施方案中，本说明书公开了一种透析机，包括：控制器单元，其中所述控制器单元包括：门，其具有内部面；具有面板的外壳，其中所述外壳和面板限定配置成接收所述门的所述内部面的凹陷区域；以及歧管接收器，其被固定地附接到所述面板；以及基部单元，其中所述基部单元包括：平面表面，其用于接收流体的容器；秤，其与所述平面表面集成；加热器，其与所述平面表面热连通；以及钠传感器，其与所述平面表面电磁连通。In one embodiment, the specification discloses a dialysis machine comprising: a controller unit, wherein the controller unit includes: a door having an interior face; a housing having a panel, wherein the housing and panel define a receiving a recessed area of the interior face of the door; and a manifold receptacle fixedly attached to the panel; and a base unit, wherein the base unit includes: a planar surface for receiving a fluid a container; a scale integrated with the planar surface; a heater in thermal communication with the planar surface; and a sodium sensor in electromagnetic communication with the planar surface.
可选地，所述歧管接收器包括成形的引导器、销或闩锁中的至少一个。所述面板配置成提供通向多个泵的通路。所述面板配置成提供通向大致平行对准的四个蠕动泵的通路。所述内部面包括四个泵靴(pumpshoe)。当所述门容纳到所述凹陷区域中时，所述四个泵靴中的每个与所述四个蠕动泵中的一个对准。所述泵靴中的至少一个通过构件和弹簧可动地附接到所述门。所述构件是螺栓。Optionally, the manifold receiver includes at least one of a shaped guide, pin or latch. The panel is configured to provide access to a plurality of pumps. The panel is configured to provide access to four peristaltic pumps aligned generally in parallel. The inner face includes four pumpshoes. Each of the four pump shoes aligns with one of the four peristaltic pumps when the door is received into the recessed area. At least one of the pump shoes is movably attached to the door by a member and a spring. The members are bolts.
可选地，所述控制器单元还包括用于测量所述构件的运动的传感器。所述控制器单元还包括用于接收来自所述传感器的对所述构件的所述运动的测量并且基于所述测量确定流体压力的控制器。Optionally, the controller unit further comprises a sensor for measuring the movement of the member. The controller unit also includes a controller for receiving a measurement of the movement of the member from the sensor and determining a fluid pressure based on the measurement.
可选地，所述机器配置成使用约六升的水进行透析治疗，其中所述水来自非无菌的源。所述歧管接收器配置成接收限定与第二流动路径流体地隔离的第一流动路径的模制塑料基板。所述第一和第二流动路径中的每个具有在1.5mm至7.22mm的范围内的水力直径。所述模制塑料基板结合到多个管路，并且其中所述多个管路结合到透析器。所述控制器单元还包括连接到所述外壳的外部的构件，其中所述构件配置成物理地接收所述透析器。Optionally, the machine is configured to use about six liters of water for dialysis treatment, wherein the water comes from a non-sterile source. The manifold receptacle is configured to receive a molded plastic substrate defining a first flow path fluidly isolated from a second flow path. Each of the first and second flow paths has a hydraulic diameter in the range of 1.5mm to 7.22mm. The molded plastic substrate is bonded to a plurality of tubing, and wherein the plurality of tubing is bonded to a dialyzer. The controller unit also includes a member coupled to an exterior of the housing, wherein the member is configured to physically receive the dialyzer.
可选地，所述基部单元还包括连接到所述基部单元的外部的构件，其中所述构件配置成物理地接收所述透析器。所述多个管路适于可拆卸地附接到吸附剂盒。所述基部单元还包括连接到所述基部单元的外部表面的构件，其中所述构件配置成物理地接收所述吸附剂盒。所述控制器单元包括底表面，其中所述底表面包括第一物理接口和第一数据接口。Optionally, the base unit further comprises a member connected to the exterior of the base unit, wherein the member is configured to physically receive the dialyzer. The plurality of tubing is adapted to be removably attached to the sorbent cartridge. The base unit also includes a member coupled to an exterior surface of the base unit, wherein the member is configured to physically receive the sorbent cartridge. The controller unit includes a bottom surface, wherein the bottom surface includes a first physical interface and a first data interface.
可选地，所述基部单元具有顶表面，并且其中所述顶表面包括配置成配合所述第一物理接口的第二物理接口和能够与所述第一数据接口连接的第二数据接口。所述秤包括多个挠曲部和霍尔传感器，其中所述挠曲部中的每个与所述平面表面物理连通，并且其中所述霍尔传感器中的每个配置成感测物理位移。所述钠传感器包括电导传感器。Optionally, said base unit has a top surface, and wherein said top surface comprises a second physical interface configured to mate with said first physical interface and a second data interface connectable to said first data interface. The scale includes a plurality of flexures and Hall sensors, wherein each of the flexures is in physical communication with the planar surface, and wherein each of the Hall sensors is configured to sense physical displacement. The sodium sensor includes a conductivity sensor.
可选地，所述电导传感器包括具有多个匝的线圈、与所述线圈电连通的电容器、以及能量源，其中所述线圈和电容器限定电路，所述能量源与所述电路电连通。所述电导传感器基于保整个电容器恒定电压所需要的来自所述能量源的能量输入而输出指示所述流体中的钠浓度的值。Optionally, the conductivity sensor includes a coil having a plurality of turns, a capacitor in electrical communication with the coil, and an energy source, wherein the coil and capacitor define an electrical circuit, the energy source in electrical communication with the electrical circuit. The conductivity sensor outputs a value indicative of the sodium concentration in the fluid based on the energy input from the energy source required to maintain a constant voltage across the capacitor.
可选地，所述基部单元包括至少一个湿度传感器。所述基部单元包括能够处于开放状态或处于关闭状态的门，并且其中当门的所述内部面容纳在所述凹陷区域中时所述门被物理地阻止处于开放状态。所述基部单元包括能够处于开放状态或处于关闭状态的门，并且其中当门的所述内部面在所述凹陷区域中时所述门被物理地锁定处于关闭状态。所述控制器单元包括多个传感器，其在门的所述内部面在所述凹陷区域中时与模制塑料基板连通。所述多个传感器中的至少一个包括压力换能器。所述压力换能器与集成到所述模制塑料基板中的柔性膜压力连通。Optionally, the base unit includes at least one humidity sensor. The base unit includes a door capable of an open state or a closed state, and wherein the door is physically prevented from being in the open state when the interior face of the door is received in the recessed area. The base unit includes a door capable of an open state or a closed state, and wherein the door is physically locked in the closed state when the inner face of the door is in the recessed area. The controller unit includes a plurality of sensors in communication with a molded plastic substrate when the interior face of the door is in the recessed area. At least one of the plurality of sensors includes a pressure transducer. The pressure transducer is in pressure communication with a flexible membrane integrated into the molded plastic substrate.
可选地，所述控制器单元包括与所述模制塑料基板连通的至少一个阀部件。所述控制器单元包括配置成激活所述阀部件的多个程序指令，并且其中所述阀部件的激活使流体流动被引导通过所述模制塑料基板中的两个分离的流体路径中的一个。所述阀部件的激活取决于血液净化系统的操作模式。Optionally, said controller unit comprises at least one valve member in communication with said molded plastic substrate. The controller unit includes a plurality of program instructions configured to activate the valve member, and wherein activation of the valve member causes fluid flow to be directed through one of two separate fluid paths in the molded plastic substrate . Activation of the valve member depends on the mode of operation of the blood purification system.
可选地，所述阀部件具有开放位置和关闭位置，并且其中所述阀部件包括：孔口关闭构件，其毗邻于流体可流动通过的孔口；位移构件，其具有第一部分和第二部分，其中所述第一部分在阀部件处于所述开放位置时毗邻于所述孔口关闭构件；第一磁体和第二磁体，其中所述第一和第二磁体足够地紧邻于所述位移构件，以将磁力施加在所述位移构件上；以及致动器，其用于产生磁场来移动所述位移构件朝向所述第一磁体，使所述第一部分压靠着所述孔口关闭构件，并且使孔口关闭构件关闭所述孔口。Optionally, the valve member has an open position and a closed position, and wherein the valve member comprises: an orifice closing member adjacent to the orifice through which fluid may flow; a displacement member having a first portion and a second portion , wherein said first portion is adjacent to said orifice closing member when the valve member is in said open position; a first magnet and a second magnet, wherein said first and second magnets are sufficiently proximate to said displacement member, to apply a magnetic force on the displacement member; and an actuator for generating a magnetic field to move the displacement member toward the first magnet, press the first portion against the orifice closing member, and An orifice closing member is caused to close the orifice.
可选地，所述第一部分包括外壳、弹性材料、杆以及在所述弹性材料和所述杆之间的缝隙。光学传感器定位成感测所述阀部件中的缝隙是存在还是不存在。所述第一部分包括杆，且所述位移构件的所述第二部分是具有比所述杆更大的直径的金属体。所述杆被结合到柱体。所述第一磁体比所述第二磁体更大。所述孔口关闭构件包括膜片、弹性材料和可压缩材料中的至少一个。所述孔口关闭构件压靠着阀座来关闭所述孔口。Optionally, said first part comprises a housing, an elastic material, a rod and a gap between said elastic material and said rod. An optical sensor is positioned to sense the presence or absence of a gap in the valve member. The first part comprises a rod and the second part of the displacement member is a metal body having a larger diameter than the rod. The rod is bonded to the cylinder. The first magnet is larger than the second magnet. The orifice closing member includes at least one of a diaphragm, an elastic material, and a compressible material. The orifice closing member presses against the valve seat to close the orifice.
可选地，所述阀部件包括：孔口关闭构件，其毗邻于流体可流动通过的孔口，其中所述孔口关闭构件在阀处于关闭位置时压靠着阀座；可动构件，其相对于所述孔口关闭构件物理地可动，其中所述可动构件从当所述阀处于开放位置时的第一位置运动至当所述阀处于所述关闭位置时的第二位置，并且其中，在所述第二位置中，可动构件压靠着孔口关闭构件以促使所述孔口关闭构件压靠着所述阀座；第一磁体和第二磁体，其具有分离部，其中所述第一磁体和第二磁体在所述分离部中产生磁场，并且其中所述磁场具有方向；以及致动器，其能够产生电磁力，其中所述电磁力反向所述磁场的方向。Optionally, the valve part comprises: an orifice closing member adjacent to the orifice through which fluid may flow, wherein the orifice closing member presses against the valve seat when the valve is in the closed position; a movable member which physically movable relative to the orifice closing member, wherein the movable member moves from a first position when the valve is in the open position to a second position when the valve is in the closed position, and wherein, in said second position, the movable member presses against the orifice closing member to urge said orifice closing member against said valve seat; a first magnet and a second magnet having a separate portion, wherein The first magnet and the second magnet generate a magnetic field in the separation part, and wherein the magnetic field has a direction; and an actuator capable of generating an electromagnetic force, wherein the electromagnetic force is opposite to the direction of the magnetic field.
可选地，所述透析机包括定位成感测缝隙是存在还是不存在的光学传感器。所述第一磁体和第二磁体提供用于所述可动构件的运动的支承表面。具有第一磁极的第一磁体比具有第二磁极的第二磁体更大。所述第一磁极和第二磁极彼此排斥，并且其中所述第一磁体和第二磁体配置成使所述第一磁极和第二磁极面向彼此。Optionally, the dialysis machine includes an optical sensor positioned to sense the presence or absence of a gap. The first and second magnets provide bearing surfaces for movement of the movable member. A first magnet with a first pole is larger than a second magnet with a second pole. The first and second magnetic poles repel each other, and wherein the first and second magnets are configured such that the first and second magnetic poles face each other.
可选地，所述控制器单元还包括具有第一稳定状态和第二稳定状态的阀，其中所述阀包括磁体，其中将能量输入到所述阀中产生使位移构件在所述控制器单元内运动的磁力，其中所述位移构件的运动促使在所述第一状态和所述第二状态之间改变，并且其中所述第一或第二状态的保持不需要能量输入。Optionally, the controller unit further includes a valve having a first stable state and a second stable state, wherein the valve includes a magnet, wherein input of energy into the valve produces a displacement member in the controller unit A magnetic force of internal motion, wherein movement of said displacement member causes a change between said first state and said second state, and wherein maintenance of said first or second state does not require energy input.
可选地，所述模制塑料基板具有孔口，其中所述孔口在所述阀处于所述第一稳定状态时对流体流动关闭，并且其中所述孔口在所述阀处于所述第二稳定状态时对流体流动开放。所述孔口在所述位移构件把材料压入所述孔口中时对流体流动关闭。所述多个传感器中的至少一个是流量计。Optionally, said molded plastic substrate has an orifice, wherein said orifice is closed to fluid flow when said valve is in said first steady state, and wherein said orifice is closed to fluid flow when said valve is in said first stable state. 2 Open to fluid flow at steady state. The orifice is closed to fluid flow when the displacement member forces material into the orifice. At least one of the plurality of sensors is a flow meter.
可选地，所述流量计包括至少两个探针，所述探针中的每个具有主体和定位在所述模制塑料基板上的接触表面，其中所述至少两个探针中的第一个响应于第一热信号而产生在流过所述模制塑料基板的流体内的热波，且所述至少两个探针中的第二个感测在所述流体内的所述热波。所述流量计还包括基准信号发生器，其中所述基准信号发生器输出基准信号。所述流量计还包括热源，其中所述热源接收来自所述基准信号发生器的所述基准信号，配置成与所述至少两个探针中的第一个热接合，并且产生具有来源于所述基准信号的相位的所述第一热信号。所述流量计还包括温度传感器，其中所述温度传感器配置成与所述第二探针热接合，并且产生具有来源于所述热波的相位的第二热信号。所述流量计还包括倍增器，该倍增器用于接收来自所述基准信号发生器的输入信号、用于接收所述第二热信号并且用于输出第三信号。所述流量计还包括用于接收来源于所述第三信号的信号并且用于接收来自所述基准信号发生器的所述基准信号的低通滤波器，其中所述低通滤波器基于所述基准信号调制其截止频率。Optionally, the flow meter comprises at least two probes, each of the probes having a body and a contact surface positioned on the molded plastic substrate, wherein a first of the at least two probes One generates a heat wave in a fluid flowing through the molded plastic substrate in response to a first heat signal, and a second of the at least two probes senses the heat in the fluid Wave. The flow meter also includes a reference signal generator, wherein the reference signal generator outputs a reference signal. The flow meter also includes a heat source, wherein the heat source receives the reference signal from the reference signal generator, is configured to be in thermal engagement with the first of the at least two probes, and generates a signal derived from the The first thermal signal of the phase of the reference signal. The flow meter also includes a temperature sensor, wherein the temperature sensor is configured to thermally engage the second probe and generate a second thermal signal having a phase derived from the thermal wave. The flow meter also includes a multiplier for receiving an input signal from the reference signal generator, for receiving the second thermal signal, and for outputting a third signal. The flow meter also includes a low pass filter for receiving a signal derived from the third signal and for receiving the reference signal from the reference signal generator, wherein the low pass filter is based on the The reference signal modulates its cutoff frequency.
可选地，所述第二探针与所述第一探针分隔小于两英寸的距离。所述透析机还包括用于放大所述第三信号并且产生来源于所述第三信号的信号的放大器。所述至少两个探针中的每个的主体具有在0.03英寸至0.15英寸的范围内的直径。所述至少两个探针中的每个的接触表面具有在0.025英寸至0.2英寸的范围内的直径。所述第二探针包括热敏电阻器。所述低通滤波器产生经滤波的信号，并且其中所述基准信号发生器至少部分地基于所述经滤波的信号产生所述基准信号。所述流量计动态地调整所述基准信号以保持恒定频率。所述流量计动态地调整所述基准信号以保持恒定相位。Optionally, the second probe is separated from the first probe by a distance of less than two inches. The dialysis machine also includes an amplifier for amplifying the third signal and generating a signal derived from the third signal. The body of each of the at least two probes has a diameter in the range of 0.03 inches to 0.15 inches. The contact surface of each of the at least two probes has a diameter in the range of 0.025 inches to 0.2 inches. The second probe includes a thermistor. The low pass filter produces a filtered signal, and wherein the reference signal generator produces the reference signal based at least in part on the filtered signal. The flow meter dynamically adjusts the reference signal to maintain a constant frequency. The flow meter dynamically adjusts the reference signal to maintain a constant phase.
可选地，所述流量计配置成将光束投射到在所述模制塑料基板内的流体中；探测在流体中的上游第一点处和下游第二点处的所得到的声信号；确定在流体中的上游探测到的所述声信号和下游探测到的所述声信号之间的相位差；并且从所述被确定的相位差计算所述流体的流量。所述相位差通过将代表在上游和下游探测到的所述声信号相位的信号相减来确定。Optionally, the flow meter is configured to project a beam of light into the fluid within the molded plastic substrate; detect the resulting acoustic signal at a first upstream point and a second downstream point in the fluid; determine a phase difference between said acoustic signal detected upstream in the fluid and said acoustic signal detected downstream; and calculating a flow rate of said fluid from said determined phase difference. The phase difference is determined by subtracting signals representing the phase of the acoustic signal detected upstream and downstream.
可选地，所述流量计包括用于将光束投射到流过所述模制塑料基板的透明片段的流体中的光学系统；用于探测在所述透明片段的上游的第一点处的声信号的第一声波探测器；用于探测在所述透明片段的下游的第二点处的所述声信号的第二声波探测器；以及用于确定在上游探测到的所述声信号和在下游探测到的所述声信号之间的相位差并且用于从所确定的相位差计算所述模制塑料基板中的流体的流量的处理器。Optionally, the flow meter includes an optical system for projecting a beam of light into the fluid flowing through the transparent section of the molded plastic substrate; for detecting acoustic noise at a first point upstream of the transparent section. a first acoustic detector for a signal; a second acoustic detector for detecting said acoustic signal at a second point downstream of said transparent segment; and for determining said acoustic signal detected upstream and A phase difference between the acoustic signals is detected downstream and a processor is used to calculate the flow rate of the fluid in the molded plastic substrate from the determined phase difference.
用于确定所述相位差的处理器包括减法单元。所述光学系统是脉冲激光系统。所述光束沿垂直于所述流体的流动的方向投射。所述流量计具有在20ml/min至600ml/min之间的操作性感测范围。所述流量计具有在20ml/min至600ml/min之间的操作性感测范围。所述控制器单元还包括用于探测内嵌在模制塑料基板中的识别数据的读取器。所述控制器单元还包括适于在所述门处于所述凹陷区域中时与模制塑料基板热连通的温度传感器。The processor for determining said phase difference includes a subtraction unit. The optical system is a pulsed laser system. The light beam is projected in a direction perpendicular to the flow of the fluid. The flow meter has an operational sensing range between 20ml/min and 600ml/min. The flow meter has an operational sensing range between 20ml/min and 600ml/min. The controller unit also includes a reader for detecting identification data embedded in the molded plastic substrate. The controller unit also includes a temperature sensor adapted to be in thermal communication with the molded plastic substrate when the door is in the recessed area.
可选地，所述控制器单元包括用于确定至患者的血液管线连接部是否已经断开的断开监视器。所述断开监视器包括：压力换能器，其与所述歧管中的血液流动路径压力连通，其中所述压力换能器产生指示所述血液流动路径中的脉冲信号的信号；心脏基准信号发生器，其中所述心脏基准信号发生器探测并产生指示所述患者的脉搏的信号；压力换能器数据接收器，其中所述压力换能器数据接收器接收指示所述血液流动路径中的脉冲信号的所述信号；心脏基准信号接收器，其中所述心脏基准信号接收器接收指示所述患者的脉搏的所述信号；以及处理器，其中所述处理器使指示所述血液流动路径中的脉冲信号的所述信号和指示所述患者的脉搏的所述信号交叉相关以产生指示断开至所述患者的血液管线连接的数据。Optionally, the controller unit comprises a disconnection monitor for determining whether the blood line connection to the patient has been disconnected. The disconnect monitor includes: a pressure transducer in pressure communication with a blood flow path in the manifold, wherein the pressure transducer generates a signal indicative of a pulse signal in the blood flow path; a cardiac reference a signal generator, wherein the cardiac reference signal generator detects and generates a signal indicative of the patient's pulse; a pressure transducer data receiver, wherein the pressure transducer data receiver receives a signal indicative of a pulse in the blood flow path said signal of a pulse signal; a cardiac reference signal receiver, wherein said cardiac reference signal receiver receives said signal indicative of said patient's pulse; and a processor, wherein said processor causes said signal indicative of said blood flow path The signal of the pulse signal in and the signal indicative of the patient's pulse are cross-correlated to generate data indicative of disconnection of the blood line to the patient.
可选地，所述断开监视器还包括控制器，其中所述控制器基于断开至所述患者的血液管线连接的所述数据触发警报器。所述断开监视器还包括控制器，其中所述控制器基于断开至患者的血液管线连接的所述数据来关闭透析泵。Optionally, the disconnection monitor further includes a controller, wherein the controller triggers an alarm based on the data of a bloodline disconnection to the patient. The disconnect monitor also includes a controller, wherein the controller shuts down the dialysis pump based on the data of disconnection of the blood line connection to the patient.
可选地，所述压力换能器非侵入地产生指示所述血液流动路径中的脉冲信号的信号。所述处理器通过计算在指定的时间框架内的指示所述血液回路中的脉冲信号的信号和指示患者脉搏的所述信号的相应成对点的乘积的和来使指示所述血液回路中的脉冲信号的所述信号和指示患者脉搏的所述信号交叉相关。Optionally, the pressure transducer non-invasively generates a signal indicative of a pulse signal in the blood flow path. The processor causes the pulse signal in the blood circuit to be indicative of a pulse signal in the blood circuit by calculating a sum of products of corresponding pairs of points of a signal indicative of a pulse signal in the blood circuit and a signal indicative of a patient pulse within a specified time frame. The signal of the pulse signal and the signal indicative of the pulse of the patient are cross-correlated.
可选地，所述断开监视器还包括用于指导患者在启动透析泵之前首先附接所述心脏信号基准发生器的程序指令。所述断开监视器还包括用于指导所述系统在启动透析泵之前捕获指示所述血液流动路径中的脉冲信号的所述信号的程序指令。Optionally, the disconnect monitor further includes program instructions for instructing the patient to first attach the cardiac signal reference generator before activating the dialysis pump. The disconnect monitor also includes program instructions for directing the system to capture the signal indicative of a pulse signal in the blood flow path prior to activating the dialysis pump.
可选地，所述控制器单元还包括：显示器；秤；条形码读取器；以及存储多个程序指令的存储器，其中在执行时，所述指令产生：a)用于在所述显示器上呈现的第一图形用户界面，其中所述第一图形用户界面显示需要在透析治疗中使用的每个添加剂；b)用于在所述显示器上呈现的第二图形用户界面，其中所述第二图形用户界面提示所述系统的用户提交多个添加剂来使用所述条形码扫描器进行扫描；以及c)用于在所述显示器上呈现的第三图形用户界面，其中所述第三图形用户界面提示所述系统的用户提交多个添加剂来使用所述秤进行测量。Optionally, the controller unit further comprises: a display; a scale; a barcode reader; and a memory storing a plurality of program instructions, wherein when executed, the instructions generate: a) for presentation on the display b) a second graphical user interface for presentation on said display, wherein said second graphical user interface a user interface prompting a user of the system to submit a plurality of additives to scan using the barcode scanner; and c) a third graphical user interface for presentation on the display, wherein the third graphical user interface prompts the A user of the system submits a number of additives for measurement using the scale.
可选地，所述秤是数字秤。所述条形码扫描器提供成功读取的视觉指示。所述存储器还包括将多个添加剂名称与多个条形码相关联的表格。所述存储器还包括将多个添加剂与多个重量值相关联的表格。所述第一图形用户界面显示添加剂包装的视觉表示。所述第三图形用户界面仅在添加剂的条形码不被识别时提示所述系统的用户提交添加剂来使用所述秤进行测量。所述第三图形用户界面仅在用于添加剂的条形码不可用时提示所述系统的用户提交添加剂来使用所述秤进行测量。Optionally, said scale is a digital scale. The barcode scanner provides a visual indication of a successful read. The memory also includes a table associating a plurality of additive names with a plurality of barcodes. The memory also includes a table associating a plurality of additives with a plurality of weight values. The first graphical user interface displays a visual representation of an additive package. The third graphical user interface prompts a user of the system to submit an additive for measurement using the scale only if the barcode of the additive is not recognized. The third graphical user interface prompts a user of the system to submit an additive for measurement using the scale only if a barcode for the additive is not available.
可选地，所述控制器单元还包括：显示器；秤，其包括多个磁体；电子读取器；以及存储多个程序指令的存储器，其中在执行时，所述指令产生：a)用于在所述显示器上呈现的第一图形用户界面，其中所述第一图形用户界面提示所述系统的用户提交多个添加剂来使用所述条形码扫描器进行扫描；以及b)用于在所述显示器上呈现的第二图形用户界面，其中所述第二图形用户界面提示所述系统的用户提交多个添加剂来使用所述秤进行测量。Optionally, the controller unit further comprises: a display; a scale including a plurality of magnets; an electronic reader; and a memory storing a plurality of program instructions, wherein when executed, the instructions generate: a) for a first graphical user interface presented on the display, wherein the first graphical user interface prompts a user of the system to submit a plurality of additives to be scanned using the barcode scanner; and b) for displaying on the display The second graphical user interface presented above, wherein the second graphical user interface prompts a user of the system to submit a plurality of additives for measurement using the scale.
可选地，在执行时，所述指令还产生用于在所述显示器上呈现的第三图形用户界面，其中所述第三图形用户界面显示需要在所述透析治疗中使用的每个添加剂。所述秤是数字秤，并且其中所述数字秤产生代表放置在所述数字秤上的物体的重量的数据。所述数字秤还包括至少三个挠曲部。所述挠曲部中的每个包括磁体和相应的霍尔传感器。Optionally, when executed, the instructions also generate a third graphical user interface for presentation on the display, wherein the third graphical user interface displays each additive required for use in the dialysis treatment. The scale is a digital scale, and wherein the digital scale generates data representing the weight of an object placed on the digital scale. The digital scale also includes at least three flexures. Each of the flexures includes a magnet and a corresponding Hall sensor.
可选地，所述透析系统还包括模制塑料基板，其中所述模制塑料基板包括限定在其中的第一流动路径和第二流动路径，并且其中所述第一流动路径和所述第二流动路径被阀流体地分隔。所述控制器单元还包括存储多个程序指令的存储器，其中所述程序指令配置成根据所选择的操作模式来限定所述阀的第一状态和所述阀的第二状态。所选择的操作模式或是预充模式(primingmode)或是治疗模式。所述阀的第一状态将所述第一流动路径置于与所述第二流动路径流体连通。所述阀的第二状态将所述第一流动路径置于与所述第二流动路径流体隔离。所述透析系统还包括模制塑料基板，其中所述基板包括用于将流体输注入患者的第一流体回路以及用于从患者移除流体的第二流体回路。Optionally, the dialysis system further comprises a molded plastic substrate, wherein the molded plastic substrate includes a first flow path and a second flow path defined therein, and wherein the first flow path and the second flow path The flow paths are fluidly separated by valves. The controller unit also includes a memory storing a plurality of program instructions, wherein the program instructions are configured to define a first state of the valve and a second state of the valve in accordance with the selected mode of operation. The selected mode of operation is either a priming mode or a therapy mode. A first state of the valve places the first flow path in fluid communication with the second flow path. The second state of the valve places the first flow path in fluid isolation from the second flow path. The dialysis system also includes a molded plastic base plate, wherein the base plate includes a first fluid circuit for infusing fluid into the patient and a second fluid circuit for removing fluid from the patient.
可选地，所述控制器单元还包括配置成在所述第一回路和所述第二回路上交替操作的第一泵；配置成在所述第二回路和所述第一回路上交替操作的第二泵；以及用于使所述第一泵在所述第一回路和所述第二回路上可选操作并且用于使所述第二泵在所述第一回路和所述第二回路上可选操作的控制器，其中所述第一泵和第二泵中的每个在给定的时间仅操作一个回路。Optionally, said controller unit further comprises a first pump configured to alternately operate on said first circuit and said second circuit; configured to alternately operate on said second circuit and said first circuit and a second pump for selectively operating said first pump on said first circuit and said second circuit and for operating said second pump on said first circuit and said second A controller for selectable operation on circuits, wherein each of said first and second pumps operates only one circuit at a given time.
可选地，相比于所述第二泵，所述第一泵每单位时间泵送较高量的流体。所述第一和第二泵在所述第一和第二回路上交替操作达一定的时间段，其中所述时间段来源于由所述第一和第二泵每单位时间泵送的流体的量的可允许的差异。所述第一和第二泵是蠕动泵。所述透析系统还包括用于均衡所述第一和第二回路之间的压力差的限流器。所述限流器是主动式的，并且基于来源于所述第一回路中的第一压力传感器和来源于所述第二回路中的第二压力传感器的所测量的压力差来均衡所述压力差。Optionally, said first pump pumps a higher amount of fluid per unit time than said second pump. The first and second pumps are alternately operated on the first and second circuits for a period of time, wherein the period of time is derived from the amount of fluid pumped by the first and second pumps per unit of time The allowable difference in quantity. The first and second pumps are peristaltic pumps. The dialysis system also includes a flow restrictor for equalizing the pressure differential between the first and second circuits. The flow restrictor is active and equalizes the pressure based on a measured pressure difference derived from a first pressure sensor in the first circuit and from a second pressure sensor in the second circuit Difference.
可选地，所述面板还包括通向通道的由两个倾斜表面限定的漏斗，并且其中所述通道包括至少一个湿度传感器。当所述门容纳在所述凹陷区域中时，所述漏斗位于所述歧管下方并且配置成将从所述歧管泄漏的流体引导朝向所述湿度传感器。Optionally, said panel further comprises a funnel leading to a channel defined by two inclined surfaces, and wherein said channel comprises at least one humidity sensor. The funnel is positioned below the manifold and is configured to direct fluid leaking from the manifold toward the humidity sensor when the door is received in the recessed area.
可选地，所述控制器单元的底表面适于可拆卸地附接到所述基部单元的顶表面。所述控制器单元与所述基部单元电连通。所述控制器单元与所述基部单元物理地分离。所述控制器单元与所述基部单元数据通信。所述控制器单元与所述基部单元流体连通。Optionally, the bottom surface of the controller unit is adapted to be detachably attachable to the top surface of the base unit. The controller unit is in electrical communication with the base unit. The controller unit is physically separate from the base unit. The controller unit is in data communication with the base unit. The controller unit is in fluid communication with the base unit.
在另一个实施方案中，本发明涉及一种透析机，包括：第一单元，其中所述第一单元包括：门，其具有第一面；外壳，其附接到所述门，其中外壳具有第二面；至少一个歧管接收器，其固定地附接到所述第二面；以及显示器，其用于显示图形用户界面；以及第二单元，其中所述第二单元包括：平面表面，其用于支撑流体的容器；称重装置，其与所述平面表面集成；加热器，其与所述平面表面热连通；以及钠传感器，其紧邻于所述平面表面。In another embodiment, the present invention is directed to a dialysis machine comprising: a first unit, wherein the first unit comprises: a door having a first face; a housing attached to the door, wherein the housing has a second face; at least one manifold receiver fixedly attached to said second face; and a display for displaying a graphical user interface; and a second unit, wherein said second unit comprises: a planar surface, A container for supporting fluid; a weighing device integrated with the planar surface; a heater in thermal communication with the planar surface; and a sodium sensor in close proximity to the planar surface.
可选地，所述歧管接收器配置成接收模制塑料基板，该模制塑料基板限定与第二流动路径流体地隔离的第一流动路径。所述模制塑料基板包括：第一层；第二层；由所述第一层的第一表面和所述第二层的第一表面限定的第一流动路径；由所述第一层的第一表面和所述第二层的第一表面限定的第二流动路径；以及阀，其与所述第一流动路径和所述第二流动路径二者都流体连通，其中所述阀具有第一状态和第二状态，并且其中当处于所述第一状态时，所述第一流动路径和第二流动路径流体隔离，并且当处于所述第二状态时，所述第一流动路径和第二流动路径流体连通。Optionally, the manifold receptacle is configured to receive a molded plastic substrate defining a first flow path fluidly isolated from a second flow path. The molded plastic substrate includes: a first layer; a second layer; a first flow path defined by a first surface of the first layer and a first surface of the second layer; A second flow path defined by the first surface and the first surface of the second layer; and a valve in fluid communication with both the first flow path and the second flow path, wherein the valve has a first a state and a second state, and wherein when in the first state, the first flow path and the second flow path are fluidly isolated, and when in the second state, the first flow path and the second flow path The two flow paths are in fluid communication.
可选地，所述模制塑料基板包括与第二多个端口相对对准的第一多个端口。所述第一多个端口和第二多个端口中的至少一个包括具有外部圆柱形外壳的构件，其中所述构件具有由中心轴线限定的内部空间。所述中心轴线相对于所述塑料基板所处的平面成一定的角度。所述角度在5度至15度的范围内。所述第一多个端口中的至少一个由具有第一直径和垂直于所述第一直径的第二直径的横截面区域限定。所述第一多个端口中的至少一个连接到由具有第三直径和垂直于所述第三直径的第四直径的横截面区域限定的端口通道，其中所述第三直径大于所述第一直径，并且其中所述第四直径小于所述第二直径。所述端口通道包括至少一个具有小于所述第四直径的高度的突出构件。所述端口通道被柔性膜覆盖。所述端口通道包括至少一个配置成防止柔性膜塌陷到所述端口通道中并且完全堵塞所述端口通道的突出部。所述端口通道的所述横截面区域不同于所述端口的所述横截面区域，并且所述端口通道的所述横截面区域配置成保持穿过所述端口并且进入所述端口通道的流体的大致恒定的速度。Optionally, the molded plastic substrate includes a first plurality of ports in opposite alignment with a second plurality of ports. At least one of the first and second plurality of ports includes a member having an outer cylindrical shell, wherein the member has an interior space defined by a central axis. The central axis forms a certain angle with respect to the plane where the plastic substrate is located. The angle is in the range of 5 degrees to 15 degrees. At least one of the first plurality of ports is defined by a cross-sectional area having a first diameter and a second diameter perpendicular to the first diameter. At least one of the first plurality of ports is connected to a port channel defined by a cross-sectional area having a third diameter and a fourth diameter perpendicular to the third diameter, wherein the third diameter is larger than the first diameter, and wherein the fourth diameter is smaller than the second diameter. The port passage includes at least one protruding member having a height less than the fourth diameter. The port channels are covered by a flexible membrane. The port channel includes at least one protrusion configured to prevent the flexible membrane from collapsing into the port channel and completely blocking the port channel. The cross-sectional area of the port channel is different from the cross-sectional area of the port, and the cross-sectional area of the port channel is configured to maintain the roughly constant speed.
可选地，所述模制塑料由第一节段、第二节段和第三节段限定；其中所述第一节段平行于所述第二节段；其中所述第三节段垂直于并附接到所述第一节段和第二节段中的每个；并且其中所述第一、第二和第三节段限定与第二流动路径流体地隔离的第一流动路径。Optionally, said molded plastic is defined by a first segment, a second segment and a third segment; wherein said first segment is parallel to said second segment; wherein said third segment is perpendicular and wherein the first, second, and third segments define a first flow path that is fluidly isolated from a second flow path.
可选地，所述第一节段具有第一多个端口，所述第二节段具有第二多个端口，并且其中所述第一和第二多个端口对准。所述第一和第二多个端口中的至少一个包括具有由中心轴线限定的内部空间的构件。所述中心轴线相对于所述第一和第二节段所处的平面成一定的角度。所述角度在5度至15度的范围内。所述第一多个端口中的至少一个由具有平行于所述第一节段的长度的第一直径和垂直于所述第一直径的第二直径的横截面区域限定。所述第一多个端口中的至少一个连接到具有具备平行于所述第一节段的长度的第三直径和垂直于所述第三直径的第四直径的横截面区域的端口通道，其中所述第三直径大于所述第一直径，并且其中所述第四直径小于所述第二直径。所述端口通道包括具有小于所述第四直径的高度的至少一个突出构件。所述端口通道被柔性膜覆盖。所述端口通道包括配置成防止柔性膜塌陷到所述端口通道中的至少一个突出部。所述端口通道的横截面区域不同于所述端口的所述横截面区域，并且所述端口通道的横截面区域配置成保持穿过所述端口并且进入所述端口通道的流体的大致恒定的雷诺数。Optionally, said first segment has a first plurality of ports, said second segment has a second plurality of ports, and wherein said first and second plurality of ports are aligned. At least one of the first and second plurality of ports includes a member having an interior space defined by a central axis. The central axis is at an angle relative to the plane in which the first and second segments lie. The angle is in the range of 5 degrees to 15 degrees. At least one of the first plurality of ports is defined by a cross-sectional area having a first diameter parallel to a length of the first segment and a second diameter perpendicular to the first diameter. At least one of the first plurality of ports is connected to a port channel having a cross-sectional area having a third diameter parallel to the length of the first segment and a fourth diameter perpendicular to the third diameter, wherein The third diameter is larger than the first diameter, and wherein the fourth diameter is smaller than the second diameter. The port passage includes at least one protruding member having a height less than the fourth diameter. The port channels are covered by a flexible membrane. The port channel includes at least one protrusion configured to prevent the flexible membrane from collapsing into the port channel. The cross-sectional area of the port channel is different from the cross-sectional area of the port, and the cross-sectional area of the port channel is configured to maintain a substantially constant Reynolds of fluid passing through the port and into the port channel. number.
可选地，所述第三节段附接到所述第一节段和所述第二节段的中心。所述第三节段不附接到所述第一节段或所述第二节段的中心。所述第一节段具有至少一个端口，其中所述端口的内部的一部分由平坦的基部限定。所述第一节段和所述第二节段具有在4至7英寸的范围内的长度和在0.5至1.5英寸的范围内的宽度。所述第三节段具有在2.5至4.5英寸的范围内的长度。所述第一节段具有第一长度和第一宽度，所述第二节段具有第二长度和第二宽度，且所述第三节段具有第三长度和第三宽度，并且其中所述第一长度和所述第二长度大于所述第三宽度，所述第一宽度和所述第二宽度小于所述第三长度。所述第一节段具有第一长度和第一宽度，所述第二节段具有第二长度和第二宽度，并且其中所述第一长度等于所述第二长度且所述第一宽度等于所述第二宽度。Optionally, said third segment is attached to the center of said first segment and said second segment. The third segment is not attached to the center of either the first segment or the second segment. The first segment has at least one port, wherein a portion of an interior of the port is defined by a planar base. The first segment and the second segment have a length in the range of 4 to 7 inches and a width in the range of 0.5 to 1.5 inches. The third segment has a length in the range of 2.5 to 4.5 inches. The first segment has a first length and a first width, the second segment has a second length and a second width, and the third segment has a third length and a third width, and wherein the The first length and the second length are greater than the third width, and the first width and the second width are smaller than the third length. The first segment has a first length and a first width, the second segment has a second length and a second width, and wherein the first length is equal to the second length and the first width is equal to the second width.
可选地，所述歧管接收器配置成接收模制塑料基板，并且其中管状节段将所述模制塑料基板连接到透析器。所述透析机包括用于将所述透析器可拆卸地附接到所述透析机的外表面的接收器。所述管状节段包括具有内部容积的一次性电导探针，其中所述内部容积接收流过所述管状节段的流体。所述一次性电导探针适于可拆卸地连接到定位在所述透析机的外表面上的匹配的探针。Optionally, the manifold receptacle is configured to receive a molded plastic substrate, and wherein a tubular segment connects the molded plastic substrate to a dialyzer. The dialysis machine includes a receptacle for removably attaching the dialyzer to an exterior surface of the dialysis machine. The tubular section includes a disposable conductivity probe having an interior volume, wherein the interior volume receives fluid flowing through the tubular section. The disposable conductivity probe is adapted to be detachably connected to a mating probe positioned on an outer surface of the dialysis machine.
在另一个实施方案中，本发明涉及一种透析机，包括：第一单元，其与第二单元数据通信，其中所述第一单元包括：门，其具有定位在所述门的内部面上的压力板；具有面板的外壳，其中所述外壳和面板限定配置成接收所述门的所述内部面的凹陷区域；对准机构，其固定地附接到所述面板，其中所述对准机构配置成将歧管可拆卸地接收在所述面板上，并且在所述门容纳在所述凹陷区域中时将所述歧管定位成靠着所述压力板；并且其中所述第二单元包括：平面表面，其用于接收流体的容器；称重装置，其与所述平面表面集成；加热器，其与所述平面表面热连通；以及钠传感器，其紧邻于所述平面表面。In another embodiment, the present invention is directed to a dialysis machine comprising: a first unit in data communication with a second unit, wherein said first unit comprises: a door having a a pressure plate; a housing having a panel, wherein the housing and panel define a recessed area configured to receive the interior face of the door; an alignment mechanism fixedly attached to the panel, wherein the alignment a mechanism configured to removably receive a manifold on the panel and position the manifold against the pressure plate when the door is received in the recessed area; and wherein the second unit Including: a planar surface for receiving a container of fluid; a weighing device integrated with the planar surface; a heater in thermal communication with the planar surface; and a sodium sensor proximate to the planar surface.
在另一个实施方案中，本发明涉及多通基于吸附剂的血液透析滤过系统，有利地在多通配置中组合血液滤过和血液透析。In another embodiment, the present invention relates to a multi-pass sorbent-based hemodiafiltration system, advantageously combining hemofiltration and hemodialysis in a multi-pass configuration.
在另一个实施方案中，本发明涉及用于血液净化系统的歧管支撑部，所述血液净化系统为例如但不限于血液透析滤过和超滤。在一个实施方案中，本发明的歧管包括其中模制有血液和透析液流动路径的复合塑料歧管。这种基于塑料的歧管可以与本发明的多通基于吸附剂的血液透析滤过系统共同使用。In another embodiment, the present invention is directed to a manifold support for a blood purification system such as, but not limited to, hemodiafiltration and ultrafiltration. In one embodiment, the manifold of the present invention comprises a composite plastic manifold with blood and dialysate flow paths molded therein. Such plastic-based manifolds may be used with the multi-pass sorbent-based hemodiafiltration system of the present invention.
在另一个实施方案中，血液净化系统部件，例如传感器、泵和一次性用品被集成到模制的歧管中。一次性物品，例如但不限于透析器和吸附剂盒，可拆卸地可加载至歧管上或者与之流体连通。一次性物品，例如但不限于透析器和吸附剂盒，固定地附接到被固定地附接到所述歧管并与之流体连通的管路。In another embodiment, blood purification system components such as sensors, pumps and disposables are integrated into a molded manifold. Disposable items, such as but not limited to dialyzers and sorbent cartridges, are removably loadable onto or in fluid communication with the manifold. Disposable items, such as but not limited to dialyzers and sorbent cassettes, are fixedly attached to tubing that is fixedly attached to and in fluid communication with the manifold.
在另一个实施方案中，超滤系统通过将血液和超滤液流动路径都模制在歧管中而被集成到歧管中。在一个实施方案中，本文公开的歧管包括可以通过组合两个塑料基板半部而制成的单一的复合塑料结构，也被称为基板或外壳。In another embodiment, the ultrafiltration system is integrated into the manifold by molding both blood and ultrafiltrate flow paths into the manifold. In one embodiment, the manifolds disclosed herein comprise a single composite plastic structure, also referred to as a base plate or housing, that can be made by combining two plastic base plate halves.
在另一个实施方案中，本发明涉及一种支撑基于电子的封锁系统的透析系统。因此，在一个实施方案中，读取器安装在系统外壳和/或歧管例如但不限于血液透析滤过和超滤歧管上，并且读取被加载到透析外壳和/或歧管上的一次性物品上的识别指示物。读取器通过网络例如公共网络或私人网络与数据库通信来检查一次性物品是否有效、精确或具有足够的完整性以是安全的并且能够使用。这通过基于物品的识别指示物从远程数据库查询关于一次性物品的信息而进行。如果一次性物品具有“无效的”或“受损的”状态，则(基于从数据库接收的信息)系统“封锁”被加载的一次性用品的使用，并且因此不允许用户继续使用该系统用于治疗。In another embodiment, the invention relates to a dialysis system supporting an electronic-based containment system. Thus, in one embodiment, the reader is mounted on a system housing and/or manifold such as, but not limited to, hemodiafiltration and ultrafiltration manifolds, and reads the Identification indicators on disposable items. The reader communicates with the database over a network, such as a public network or a private network, to check that the disposable is valid, accurate or of sufficient integrity to be safe and ready for use. This is done by querying the remote database for information about the disposable item based on the item's identification indicator. If the disposable has an "invalid" or "damaged" status, then (based on information received from the database) the system "blocks" the use of the loaded disposable, and thus does not allow the user to continue using the system for treat.
本说明书还涉及一种膜片/隔膜，集成到用于透析机的一次性歧管中并且适于由在所述透析机内并且在所述一次性歧管外部的部件压缩，所述膜片包括：凸外表面，其从所述歧管向外突出并且在第一端部和在第二端部被固定地附接到所述歧管，其中所述第一端部和第二端部之间的距离限定所述膜片的长度和高度，其中，所述膜片在所述第一端部和第二端部具有与所述歧管相同的高度，其中，所述凸外表面的高度从所述第一端部增加至相对于所述歧管的第一高度，并且其中，所述凸外表面的高度从所述第一高度减小至所述第二端部。The description also relates to a membrane/diaphragm, integrated into a disposable manifold for a dialysis machine and adapted to be compressed by a component inside said dialysis machine and external to said disposable manifold, said membrane comprising: a convex outer surface protruding outwardly from the manifold and fixedly attached to the manifold at a first end and at a second end, wherein the first end and the second end The distance between defines the length and height of the diaphragm, wherein the diaphragm has the same height as the manifold at the first end and the second end, wherein the convex outer surface The height increases from the first end to a first height relative to the manifold, and wherein the convex outer surface decreases in height from the first height to the second end.
在一个实施方案中，所述膜片/隔膜的第一高度相对于所述歧管在0.03和0.04英寸之间。In one embodiment, the first height of the membrane/diaphragm is between 0.03 and 0.04 inches relative to the manifold.
在一个实施方案中，所述膜片具有沿着从所述第一端部至所述第二端部的长度的厚度，并且其中，所述厚度沿着所述长度是大致恒定的。在一个实施方案中，所述膜片的厚度介于0.03和0.04英寸之间。In one embodiment, said diaphragm has a thickness along a length from said first end to said second end, and wherein said thickness is substantially constant along said length. In one embodiment, the thickness of the membrane is between 0.03 and 0.04 inches.
在一个实施方案中，所述膜片的总长度介于0.625和0.675英寸之间。In one embodiment, the overall length of the membrane is between 0.625 and 0.675 inches.
本说明书还涉及一种包括一个或多个具有上文所述的凸外表面的膜片的歧管。The present description also relates to a manifold comprising one or more membranes having a convex outer surface as described above.
本说明书还涉及一种膜片，集成到用于透析机的一次性歧管中并且适于由在所述透析机内并且在所述一次性歧管外部的部件压缩，所述膜片包括：第一大致平面表面，其具有第一端部和第一弯曲部，其中，所述第一端部和第一弯曲部之间的距离限定所述第一平面表面的长度和高度，其中，所述第一端部被固定地附接到所述歧管，并且其中，所述第一平面表面的所述高度大致等于所述歧管的高度；凸外表面，其从所述第一平面表面的所述第一弯曲部继续并且向外突出，所述凸外表面从所述第一弯曲部继续到第二弯曲部，其中，所述第一弯曲部和第二弯曲部之间的距离限定所述凸表面的长度和高度，其中，所述凸表面在所述第一弯曲部和所述第二弯曲部具有与所述第一平面表面相同的高度，其中，所述凸外表面的高度从所述第一弯曲部增加到相对于所述歧管的第二高度，并且其中，所述凸外表面的高度从所述第二高度减小至所述第二弯曲部；以及第二大致平面表面，其从所述第二弯曲部继续到第二端部，其中，所述第二弯曲部和第二端部之间的距离限定所述第二平面表面的长度和高度，其中，所述第二端部被固定地附接到所述歧管，并且其中，所述第二平面表面的所述高度大致等于所述第一平面表面的所述高度，且所述第二平面表面的所述长度大致等于所述第一平面表面的所述长度。The present description also relates to a membrane integrated into a disposable manifold for a dialysis machine and adapted to be compressed by components inside said dialysis machine and external to said disposable manifold, said membrane comprising: A first substantially planar surface having a first end and a first bend, wherein the distance between the first end and the first bend defines the length and height of the first planar surface, wherein the said first end is fixedly attached to said manifold, and wherein said height of said first planar surface is substantially equal to the height of said manifold; a convex outer surface extending from said first planar surface The first curved portion continues and protrudes outward, the convex outer surface continues from the first curved portion to a second curved portion, wherein the distance between the first curved portion and the second curved portion defines The length and height of the convex surface, wherein the convex surface has the same height as the first planar surface at the first bend and the second bend, wherein the height of the convex outer surface increases from the first bend to a second height relative to the manifold, and wherein the height of the convex outer surface decreases from the second height to the second bend; and a second approximately a planar surface continuing from said second bend to a second end, wherein the distance between said second bend and second end defines the length and height of said second planar surface, wherein said said second end portion is fixedly attached to said manifold, and wherein said height of said second planar surface is substantially equal to said height of said first planar surface, and said height of said second planar surface The length is substantially equal to the length of the first planar surface.
在一个实施方案中，所述凸外表面的所述第二高度相对于所述第一大致平面表面在0.03和0.04英寸之间。In one embodiment, said second height of said convex outer surface is between 0.03 and 0.04 inches relative to said first generally planar surface.
在一个实施方案中，所述膜片具有沿着从所述第一端部至所述第二端部的长度的厚度，并且其中，所述厚度沿着所述长度是大致恒定的。在一个实施方案中，所述膜片的厚度介于0.03和0.04英寸之间。In one embodiment, said diaphragm has a thickness along a length from said first end to said second end, and wherein said thickness is substantially constant along said length. In one embodiment, the thickness of the membrane is between 0.03 and 0.04 inches.
在一个实施方案中，所述膜片从所述第一平面表面的所述第一端部至所述第二平面表面的所述第二端部的总长度介于0.625和0.675英寸之间。在一个实施方案中，所述凸外表面的长度介于0.125和0.15英寸之间，且所述第一平面表面的长度和所述第二平面表面的长度介于0.25和0.2625英寸之间。In one embodiment, the total length of said diaphragm from said first end of said first planar surface to said second end of said second planar surface is between 0.625 and 0.675 inches. In one embodiment, the length of the convex outer surface is between 0.125 and 0.15 inches, and the length of the first planar surface and the length of the second planar surface are between 0.25 and 0.2625 inches.
本说明书还涉及一种包括一个或多个具有上文所述的第一和第二平面表面以及凸外表面的膜片的歧管。The present description also relates to a manifold comprising one or more diaphragms having the above-described first and second planar surfaces and a convex outer surface.
本说明书还涉及一种膜片，集成到用于透析机的一次性歧管中并且适于由在所述透析机内并且在所述一次性歧管外部的部件压缩，所述膜片包括：第一倾斜表面，其具有第一端部和第一弯曲部，其中，所述第一端部和第一弯曲部之间的距离限定所述第一倾斜表面的长度，其中，所述第一端部被固定地附接到所述歧管，并且其中，所述第一倾斜表面在所述第一端部具有第一高度并且在所述第一弯曲部具有第二高度，其中所述第一倾斜表面的所述第二高度大于所述第一倾斜表面相对于所述歧管的所述第一高度，并且其中，所述第一倾斜表面的所述第一高度大致等于所述歧管的高度；凸外表面，其从所述第一倾斜表面的所述第一弯曲部继续并且向外突出，所述凸外表面从所述第一弯曲部继续到第二弯曲部，其中，所述第一弯曲部和第二弯曲部之间的距离限定所述凸表面的长度和高度，其中，所述凸表面在所述第一弯曲部和所述第二弯曲部的高度与所述第一倾斜表面的第二高度相同，其中，所述凸外表面的高度从所述第一弯曲部增加到所述凸表面相对于所述第一倾斜表面的第二高度的第二高度，并且其中，所述凸外表面的高度从所述凸表面的所述第二高度减小至所述第二弯曲部；以及第二倾斜表面，其从所述第二弯曲部继续到第二端部，其中，所述第二弯曲部和第二端部之间的距离限定所述第二倾斜表面的长度，其中，所述第二端部被固定地附接到所述歧管，并且其中，所述第二倾斜表面在所述第二弯曲部具有第一高度并且在所述第二弯曲部具有第二高度，其中所述第二倾斜表面的所述第一高度大于所述第二倾斜表面相对于所述歧管的所述第二高度，并且其中，所述第二倾斜表面的所述第二高度大致等于所述第一倾斜表面的所述第一高度，所述第二倾斜表面的所述第一高度大致等于所述第一倾斜表面的所述第二高度，并且所述第二倾斜表面的所述长度大致等于所述第一倾斜表面的所述长度。The present description also relates to a membrane integrated into a disposable manifold for a dialysis machine and adapted to be compressed by components inside said dialysis machine and external to said disposable manifold, said membrane comprising: A first inclined surface having a first end and a first bend, wherein the distance between the first end and the first bend defines the length of the first inclined surface, wherein the first An end is fixedly attached to the manifold, and wherein the first sloped surface has a first height at the first end and a second height at the first bend, wherein the first said second height of an inclined surface is greater than said first height of said first inclined surface relative to said manifold, and wherein said first height of said first inclined surface is substantially equal to said manifold a height of ; a convex outer surface continuing from said first bend of said first inclined surface and protruding outward, said convex outer surface continuing from said first bend to a second bend, wherein said The distance between the first bend and the second bend defines the length and height of the convex surface, wherein the height of the convex surface between the first bend and the second bend is the same as the first bend a sloped surface having the same second height, wherein the height of the convex outer surface increases from the first curvature to a second height of the convex surface relative to a second height of the first sloped surface, and wherein , the height of the convex outer surface decreases from the second height of the convex surface to the second bend; and a second sloped surface continues from the second bend to a second end, wherein the distance between the second bend and the second end defines the length of the second inclined surface, wherein the second end is fixedly attached to the manifold, and wherein the The second inclined surface has a first height at the second curved portion and a second height at the second curved portion, wherein the first height of the second inclined surface is greater than that of the second inclined surface at the second height of the manifold, and wherein the second height of the second sloped surface is substantially equal to the first height of the first sloped surface, all of the second sloped surface The first height is approximately equal to the second height of the first inclined surface, and the length of the second inclined surface is approximately equal to the length of the first inclined surface.
在一个实施方案中，所述凸外表面的所述第二高度相对于所述第一倾斜表面的所述第二高度和所述第二倾斜表面的所述第一高度介于0.01与0.02英寸之间，并且所述第一倾斜表面的所述第二高度和所述第二倾斜表面的所述第一高度相对于所述歧管约为0.02英寸。In one embodiment, said second height of said convex outer surface is between 0.01 and 0.02 inches relative to said second height of said first sloped surface and said first height of said second sloped surface and the second height of the first sloped surface and the first height of the second sloped surface are about 0.02 inches relative to the manifold.
在一个实施方案中，所述膜片具有沿着从所述第一端部至所述第二端部的长度的厚度，其中所述厚度沿着所述长度是大致恒定的。在一个实施方案中，所述膜片的厚度介于0.03和0.04英寸之间。In one embodiment, said diaphragm has a thickness along a length from said first end to said second end, wherein said thickness is substantially constant along said length. In one embodiment, the thickness of the membrane is between 0.03 and 0.04 inches.
在一个实施方案中，所述膜片从所述第一倾斜表面的所述第一端部至所述第二倾斜表面的所述第二端部的总长度介于0.625和0.675英寸之间。在一个实施方案中，所述凸外表面的长度介于0.125和0.15英寸之间，且所述第一倾斜表面的长度和所述第二倾斜表面的长度介于0.25和0.2625英寸之间。In one embodiment, the total length of said diaphragm from said first end of said first inclined surface to said second end of said second inclined surface is between 0.625 and 0.675 inches. In one embodiment, the length of the convex outer surface is between 0.125 and 0.15 inches, and the length of the first sloped surface and the length of the second sloped surface are between 0.25 and 0.2625 inches.
本说明书还涉及一种包括一个或多个具有上文所述的第一和第二倾斜表面以及凸外表面的膜片的歧管。The present description also relates to a manifold comprising one or more diaphragms having the above-described first and second inclined surfaces and a convex outer surface.
这些及其他实施方案在详细描述部分中得到说明，应当参照附图来阅读详细描述部分。These and other embodiments are described in the Detailed Description, which should be read with reference to the accompanying figures.
附图说明Description of drawings
本发明的这些及其他特征和优点将被理解，因为它们通过结合附图并参照下文的详细描述而得到更好地理解，在附图中：These and other features and advantages of the present invention will be understood as they are better understood by reference to the following detailed description when taken in conjunction with the accompanying drawings, in which:
图1是本发明的透析系统的一个实施方案的前视图；Figure 1 is a front view of one embodiment of the dialysis system of the present invention;
图2是透析系统的一个实施方案的视图，示出了系统的模块性；Figure 2 is a view of one embodiment of a dialysis system illustrating the modularity of the system;
图3是透析系统的一个实施方案的前部的视图，其中门是开放的；Figure 3 is a view of the front of one embodiment of the dialysis system with the door open;
图4是便携式透析系统的一个实施方案的俯视图，其中示出了示例性的尺寸；Figure 4 is a top view of one embodiment of a portable dialysis system showing exemplary dimensions;
图5是便携式透析系统的一个实施方案的前视图，其中示出了示例性的尺寸；Figure 5 is a front view of one embodiment of a portable dialysis system showing exemplary dimensions;
图6是透析系统的另一个实施方案的前视图；Figure 6 is a front view of another embodiment of a dialysis system;
图7是透析系统的另一个实施方案的视图，表明系统的模块性；Figure 7 is a view of another embodiment of a dialysis system, illustrating the modularity of the system;
图8是透析系统的另一个实施方案的前视图；Figure 8 is a front view of another embodiment of a dialysis system;
图9是透析系统的储液器单元的一个实施方案的俯视图；Figure 9 is a top view of one embodiment of a reservoir unit of a dialysis system;
图10是定位在透析系统的储液器单元的顶表面上的示例性部件的示意图；10 is a schematic illustration of exemplary components positioned on the top surface of a reservoir unit of a dialysis system;
图11是定位在透析系统的储液器单元的顶表面上的示例性附接部件的示意图；11 is a schematic illustration of an exemplary attachment component positioned on a top surface of a reservoir unit of a dialysis system;
图12是定位在透析系统的储液器单元的顶表面上的示例性部件的示意图；12 is a schematic illustration of exemplary components positioned on the top surface of a reservoir unit of a dialysis system;
图13是定位在透析系统的控制器单元的底表面上的示例性部件的示意图：13 is a schematic illustration of exemplary components positioned on the bottom surface of a controller unit of a dialysis system:
图14是定位在透析系统的储液器单元的顶表面上的示例性连接部件的示意图；14 is a schematic illustration of an exemplary connection component positioned on a top surface of a reservoir unit of a dialysis system;
图15是透析系统的控制器单元的内部框架的一个实施方案的示意图；Figure 15 is a schematic diagram of one embodiment of the internal frame of the controller unit of the dialysis system;
图16A是本发明的透析系统的一个实施方案的前视/侧视图；Figure 16A is a front/side view of one embodiment of the dialysis system of the present invention;
图16B是本发明的透析系统的另一个实施方案的前视/侧视图；Figure 16B is a front/side view of another embodiment of the dialysis system of the present invention;
图16C是本发明的透析系统的另一个实施方案的侧视图；Figure 16C is a side view of another embodiment of the dialysis system of the present invention;
图17A是本发明的透析系统的储液器单元的一个实施方案的内结构的示意图；Figure 17A is a schematic illustration of the internal structure of one embodiment of the reservoir unit of the dialysis system of the present invention;
图17B是本发明的透析系统的储液器单元的一个实施方案的内结构的示意图；Figure 17B is a schematic illustration of the internal structure of one embodiment of the reservoir unit of the dialysis system of the present invention;
图17C是本发明的透析系统的储液器单元的一个实施方案的内结构的示意图；Figure 17C is a schematic illustration of the internal structure of one embodiment of the reservoir unit of the dialysis system of the present invention;
图17D是示例性电导传感器的电路图；Figure 17D is a circuit diagram of an exemplary conductivity sensor;
图17E是在电导传感器中使用的示例性线圈的图解；Figure 17E is a diagram of an exemplary coil for use in a conductivity sensor;
图18是在本发明的透析系统的储液器单元的一个实施方案中使用的挠曲部的示意图；Figure 18 is a schematic illustration of a flexure used in one embodiment of the reservoir unit of the dialysis system of the present invention;
图19是在本发明的透析系统的控制器单元的一个实施方案中实施的门锁定机构的示意图；Figure 19 is a schematic illustration of the door locking mechanism implemented in one embodiment of the controller unit of the dialysis system of the present invention;
图20是在本发明的透析系统的控制器单元的一个实施方案中实施的门锁定机构的示意图；Figure 20 is a schematic illustration of the door locking mechanism implemented in one embodiment of the controller unit of the dialysis system of the present invention;
图21是透析系统的一个实施方案的前部的视图，其中门是开放的并且安装有歧管；Figure 21 is a view of the front of one embodiment of a dialysis system with the door open and the manifold installed;
图22是定位在透析系统的储液器单元上的湿度传感器的一个实施方案的示意图；Figure 22 is a schematic diagram of one embodiment of a humidity sensor positioned on a reservoir unit of a dialysis system;
图23是定位在透析系统的储液器单元上的湿度传感器的一个实施方案的近视示意图；23 is a close-up schematic diagram of one embodiment of a humidity sensor positioned on a reservoir unit of a dialysis system;
图24是透析系统的储液器单元的一个实施方案的前视图，其中门是开放的；Figure 24 is a front view of one embodiment of the reservoir unit of the dialysis system with the door open;
图25是用于将吸附剂盒和/或浓缩液罐附接到透析系统的连接器机构的一个实施方案的示意图；Figure 25 is a schematic diagram of one embodiment of a connector mechanism for attaching a sorbent cartridge and/or concentrate tank to a dialysis system;
图26是第一示例性流体回路图解；26 is a first exemplary fluid circuit diagram;
图27是第二示例性流体回路图解；27 is a second exemplary fluid circuit diagram;
图28是第三示例性流体回路图解；28 is a third exemplary fluid circuit diagram;
图29是第四示例性流体回路图解；29 is a diagram of a fourth exemplary fluid circuit;
图30是示例性歧管的一个实施方案的示意图；Figure 30 is a schematic diagram of one embodiment of an exemplary manifold;
图31是示例性歧管的另一个实施方案的示意图；Figure 31 is a schematic diagram of another embodiment of an exemplary manifold;
图32是示例性歧管的另一个实施方案的示意图，其中示出了与其相关的尺寸；Figure 32 is a schematic diagram of another embodiment of an exemplary manifold showing dimensions associated therewith;
图33是示例性歧管的另一个实施方案的示意图；Figure 33 is a schematic diagram of another embodiment of an exemplary manifold;
图34是描绘了第一示例性流体流过端口的图解；Figure 34 is a diagram depicting a first exemplary fluid flow through a port;
图35是描绘了第二示例性流体流过端口的图解；35 is a diagram depicting a second exemplary fluid flow through a port;
图36是描绘了有角度的歧管端口结构的一个实施方案的图解；Figure 36 is a diagram depicting one embodiment of an angled manifold port configuration;
图37是具有大致平面基部的模制流体路径的一个实施方案的图解；Figure 37 is an illustration of one embodiment of a molded fluid path having a generally planar base;
图38是第五示例性流体回路图解；38 is a fifth exemplary fluid circuit diagram;
图39是与其他透析部件相关联地使用的示例性歧管的另一个实施方案的示意图；Figure 39 is a schematic diagram of another embodiment of an exemplary manifold for use in association with other dialysis components;
图40是示例性歧管的另一个实施方案的示意图；Figure 40 is a schematic diagram of another embodiment of an exemplary manifold;
图41是透析系统的控制器单元的一个实施方案的前视图，其中门是开放的并且安装有歧管；Figure 41 is a front view of one embodiment of the controller unit of the dialysis system with the door open and the manifold installed;
图42是透析系统的控制器单元的一个实施方案的前视图，其中门是开放的并且歧管通过使用附接引导部被安装；Figure 42 is a front view of one embodiment of the controller unit of the dialysis system with the door open and the manifold installed using the attachment guide;
图43是描绘了示例性光声流量计的电路图；Figure 43 is a circuit diagram depicting an exemplary photoacoustic flow meter;
图44描绘了由示例性光声流量计产生的多个传播信号；Figure 44 depicts a plurality of propagated signals produced by an exemplary photoacoustic flow meter;
图45是描绘了示例性热流量计的回路图；Figure 45 is a circuit diagram depicting an exemplary thermal flow meter;
图46描绘了由示例性热流量计产生的多个传播信号；Figure 46 depicts a number of propagated signals produced by an exemplary thermal flow meter;
图47描绘了限定示例性热流量计的操作的多个变量；Figure 47 depicts a number of variables that define the operation of an exemplary thermal flow meter;
图48描绘了由示例性热流量计产生的多个传播信号；Figure 48 depicts a number of propagated signals produced by an exemplary thermal flow meter;
图49描绘了限定示例性热流量计的操作的多个变量；Figure 49 depicts a number of variables that define the operation of an exemplary thermal flow meter;
图50A描绘了由示例性热流量计产生的多个传播信号；Figure 50A depicts multiple propagated signals produced by an exemplary thermal flow meter;
图50B描绘了由示例性热流量计产生的多个传播信号；Figure 50B depicts multiple propagated signals produced by an exemplary thermal flow meter;
图51描绘了限定示例性热流量计的操作的多个变量；Figure 51 depicts a number of variables that define the operation of an exemplary thermal flow meter;
图52描绘了限定示例性热流量计的操作的多个变量；Figure 52 depicts a number of variables that define the operation of an exemplary thermal flow meter;
图53是描绘了示例性热流量计的示意图；53 is a schematic diagram depicting an exemplary thermal flow meter;
图54是描绘了示例性热流量计的示意图；Figure 54 is a schematic diagram depicting an exemplary thermal flow meter;
图55描绘了由示例性热流量计产生的多个传播信号；Figure 55 depicts a number of propagated signals produced by an exemplary thermal flow meter;
图56是透析系统的控制器单元的一个实施方案的前视图，其中门是开放的并且安装有歧管；Figure 56 is a front view of one embodiment of the controller unit of the dialysis system with the door open and the manifold installed;
图57是示例性温度探针的图解；Figure 57 is a diagram of an exemplary temperature probe;
图58是示例性断开监视系统的图解；Figure 58 is an illustration of an exemplary disconnection monitoring system;
图59是示例性断开监视器的图解；Figure 59 is an illustration of an exemplary disconnect monitor;
图60是限定示例性断开探测过程的流程图；Figure 60 is a flowchart defining an exemplary disconnection detection process;
图61是示出了用于测量CVP的导液管的示例性放置的图解；Figure 61 is a diagram showing exemplary placement of a catheter for measuring CVP;
图62是示出了使用CVP测量的示例性透析系统的图解；Figure 62 is a diagram showing an exemplary dialysis system using CVP measurements;
图63是示出了导液管的示例性放置和CVP的测量的图解；Figure 63 is a diagram showing exemplary placement of a catheter and measurement of CVP;
图64是第六示例性流体回路图解；64 is a sixth exemplary fluid circuit diagram;
图65是第七示例性流体回路图解；65 is a diagram of a seventh exemplary fluid circuit;
图66是第八示例性流体回路图解；66 is an eighth exemplary fluid circuit diagram;
图67是代表使用泵互换来实现体积精确度的一个实施方案的图表；Figure 67 is a graph representing one embodiment of using pump interchange to achieve volumetric accuracy;
图68是第九示例性流体回路图解；68 is a ninth exemplary fluid circuit diagram;
图69A是第十示例性流体回路图解；69A is a tenth exemplary fluid circuit diagram;
图69B是第十一示例性流体回路图解；69B is an eleventh exemplary fluid circuit diagram;
图69C是第十二示例性流体回路图解；69C is a twelfth exemplary fluid circuit diagram;
图70是第十三示例性流体回路图解；70 is a thirteenth exemplary fluid circuit diagram;
图71A是示例性磁阀系统的第一示意图；71A is a first schematic diagram of an exemplary magnetic valve system;
图71B是示例性磁阀系统的第二示意图；71B is a second schematic diagram of an exemplary magnetic valve system;
图71C是带有凸起的凸面的歧管膜片的一个实施方案的横截面视图图示；71C is an illustration of a cross-sectional view of one embodiment of a manifold membrane with a raised convex surface;
图71D是带有在大致平面外周内的位于中央的凸起的凸出突出部的歧管膜片的一个实施方案的横截面视图图示；71D is an illustration of a cross-sectional view of one embodiment of a manifold membrane with a centrally located raised convex protrusion within a generally planar perimeter;
图71E是带有在凸起的凸出外周内的位于中央的凸起的凸出突出部的歧管膜片的一个实施方案的横截面视图图示；71E is an illustration of a cross-sectional view of one embodiment of a manifold membrane with a centrally located raised raised protrusion within a raised raised perimeter;
图72是示例性磁阀系统的部件的示意图；72 is a schematic illustration of components of an exemplary solenoid valve system;
图73是另一个示例性磁阀系统的示意图；73 is a schematic diagram of another exemplary magnetic valve system;
图74是描绘了示例性磁阀系统的操作的图解；Figure 74 is a diagram depicting the operation of an exemplary solenoid valve system;
图75是针对示例性磁阀系统的膜片位移与力相关的图表；75 is a graph of diaphragm displacement versus force for an exemplary solenoid valve system;
图76是描绘了示例性磁阀系统的操作的图解；Figure 76 is a diagram depicting the operation of an exemplary solenoid valve system;
图77是描绘了示例性磁阀系统的操作的流程图；77 is a flowchart depicting the operation of an exemplary solenoid valve system;
图78是用于透析系统的一个实施方案的示例性硬件架构的图解；Figure 78 is a diagram of an exemplary hardware architecture for one embodiment of a dialysis system;
图79是表示用于在透析系统中使用的多个添加剂的一个实施方案的图表；Figure 79 is a diagram representing one embodiment of additives for use in a dialysis system;
图80是描绘了用于使用户能够精确地加入添加剂的过程的一个实施方案的流程图；Figure 80 is a flowchart depicting one embodiment of a process for enabling a user to precisely add additives;
图81是示出了已包装的一次性试剂盒的示意图；Figure 81 is a schematic diagram showing a packaged disposable kit;
图82是示出了包括附接到多个管子的歧管和透析器的一次性试剂盒的一个实施方案的示意图；Figure 82 is a schematic diagram showing one embodiment of a disposable kit comprising a manifold and a dialyzer attached to a plurality of tubes;
图83是示出了集成到一次性用品中的电子封锁系统的一个实施方案的示意图；Figure 83 is a schematic diagram showing one embodiment of an electronic lockout system integrated into a disposable;
图84是第十四示例性流体回路图解；84 is a fourteenth exemplary fluid circuit diagram;
图85是第十五示例性流体回路图解，示出了预充操作模式；以及85 is a fifteenth exemplary fluid circuit diagram illustrating a priming mode of operation; and
图86是示例性歧管的另一个实施方案的示意图。Figure 86 is a schematic diagram of another embodiment of an exemplary manifold.
具体实施方式detailed description
虽然本发明可以以许多不同的形式被实施，但是为了促进对本发明的原理理解的目的，下面将参考在附图中示出的实施方案并且使用具体语言来描述它们。然而要理解的是不能由此来试图限制本发明的范围。在所描述的实施方案中的任何改变和进一步修改以及如本文描述的本发明原理的任何进一步的应用都被设想为本发明所涉及的领域的技术人员所正常想到的。While the invention may be embodied in many different forms, for the purposes of promoting an understanding of the principles of the invention, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe them. It is to be understood however that no limitation of the scope of the invention is thereby attempted. Any changes and further modifications in the described embodiments and any further applications of the principles of the invention as described herein are contemplated as would normally occur to one skilled in the art to which the invention pertains.
“持续时间”和其变体是指规定的治疗的时间进程，从初始至结束，无论治疗是因为病症被解决还是因为治疗由于任何原因被中止而结束。在治疗的持续时间内，可以规定多个在其期间一个或多个规定的刺激被施用于受试者的治疗周期。"Duration" and variants thereof refer to the time course of prescribed treatment, from initiation to completion, whether treatment ends because the condition is resolved or because treatment is discontinued for any reason. Over the duration of the treatment, a number of treatment periods may be prescribed during which one or more prescribed stimuli are administered to the subject.
“周期”是指在其内刺激的一个“剂量”作为规定的治疗计划的一部分被施用于受试者的时间。A "period" refers to the time during which a "dose" of stimulation is administered to a subject as part of a prescribed treatment plan.
术语“和/或”意指所列出的要素中的一个或全部或所列出的要素中的任何两个或更多个的组合。The term "and/or" means one or all of the listed elements or a combination of any two or more of the listed elements.
术语“包括”和其变体不具有限制性的意思，如果这些术语在说明书和权利要求中出现的话。The terms "comprising" and variations thereof do not have a limiting meaning if these terms appear in the description and claims.
除非另有指定，否则“一”、“一个”、“特指的那个”、“一个或多个”和“至少一个”被可互换地使用并且意指一个或一个以上。"A", "an", "the specified one", "one or more" and "at least one" are used interchangeably and mean one or more than one unless specified otherwise.
对于本文公开的任何包括分立的步骤的方法，这些步骤可以以任何可行的顺序进行。此外适当地，两个或更多个步骤的任何组合可以同时进行。For any method disclosed herein comprising discrete steps, the steps may be performed in any order feasible. Also suitably any combination of two or more steps may be performed simultaneously.
同样在本文中，数字范围的使用端点的引用包括所有的包括在该范围内的数字(例如l至5包括l、1.5、2、2.75、3、3.80、4、5等等)。除非另有指示，否则在说明书和权利要求中使用的所有的表示组成部分的量、分子量等等的数字将被理解为在所有情况下由术语“约”修饰。因此，除非另有指示为相反，否则在说明书和权利要求中提出的数字参数是近似值，其可以变化，取决于被寻求由本发明所获得的期望的性质。最起码，并且不作为限制对权利要求的范围的等效物的教导的企图，每个数字参数应当至少根据所报告的有效数字的数字并且通过应用普通的四舍五入技术被构建。Also herein, recitations of numerical ranges by endpoints include all numbers subsumed within that range (eg 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, 5, etc.). Unless otherwise indicated, all numbers expressing amounts of constituents, molecular weights, etc. used in the specification and claims are to be understood as being modified in all instances by the term "about". Accordingly, unless otherwise indicated to the contrary, the numerical parameters set forth in the specification and claims are approximations that can vary depending upon the desired properties sought to be obtained by the present invention. At the very least, and not as an attempt to limit the teaching of equivalents to the scope of the claims, each numerical parameter should at least be constructed in light of the number of reported significant digits and by applying ordinary rounding techniques.
虽然提出本发明的宽泛范围的数字范围和参数是近似值，但是在具体示例中提出的数字值被尽可能精确地报告。然而，所有的数字值固有地含有必需地来源于在它们各自的测试测量中所发现的标准偏差的范围。Notwithstanding that the numerical ranges and parameters setting forth the broad scope of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as possible. All numerical values, however, inherently contain ranges necessarily derived from the standard deviations found in their respective testing measurements.
装置结构Device structure
本说明书公开了具有改进的安全性和功能性的模块化便携式透析系统的实施方案。参照图l和2，在一个实施方案中，透析系统100、200包括可拆卸地固定到基部102、202的顶部单元101、20l。基部102、202包括用于流体储存、测量和监视的储液器122、222。顶部单元101、201(也被称为主要单元或控制器单元)包括图形用户界面114、214、泵送单元和具有动力锁和机械备用机构的门110、210，如下文进一步讨论。This specification discloses embodiments of a modular portable dialysis system with improved safety and functionality. Referring to FIGS. 1 and 2, in one embodiment, a dialysis system 100, 200 includes a top unit 101, 201 removably secured to a base 102, 202. The base 102, 202 includes a reservoir 122, 222 for fluid storage, measurement and monitoring. The top unit 101, 201 (also referred to as the main unit or controller unit) includes a graphical user interface 114, 214, a pumping unit and a door 110, 210 with a power lock and mechanical backup mechanism, as discussed further below.
扣105用于将透析器103可拆卸地固定到顶部单元10l、20l的第一侧。吸附剂盒锁定基部104、204用于将吸附剂盒107可拆卸地固定到顶部单元10l、20l的第二相反侧。应当理解的是，扣105、血液滤器103、315、吸附剂盒锁定基部104、318和吸附剂盒107、317可以定位在顶部单元10l的同一侧上，如图3所示。在任一个情况下，底部单元具有相对于顶部单元的足够较大的面积，使得托架形成在顶部单元的任一侧上以保持吸附剂盒、保持输注液罐、捕获任何溢出、和/或将任何泄漏引导到泄漏探测器中。Buckles 105 are used to detachably secure the dialyzer 103 to the first side of the top unit 101, 201. The sorbent cartridge locking base 104, 204 is used to removably secure the sorbent cartridge 107 to a second, opposite side of the top unit 101, 201. It should be understood that the clasp 105, blood filter 103, 315, sorbent cartridge locking base 104, 318 and sorbent cartridge 107, 317 may be positioned on the same side of the top unit 101 as shown in FIG. In either case, the bottom unit has a sufficiently large area relative to the top unit such that brackets are formed on either side of the top unit to hold the sorbent cartridge, hold the infusion fluid tank, catch any spillage, and/or Direct any leaks into a leak detector.
以注射器泵190的形式的抗凝血剂泵位于透析器103和门110之间。可选地，顶部单元101可以包括瓶子保持器，其具有尖的基部以将瓶子上下颠倒地容纳在瓶子保持器外壳内。输注管线连接到血液泵的入口、血液泵的出口或透析器的出口(血液侧)。输注管线还可以“穿过”空气泡探测器以感测是否/何时抗凝血剂被排空或阻挡。An anticoagulant pump in the form of a syringe pump 190 is located between the dialyzer 103 and the door 110 . Optionally, the top unit 101 may include a bottle holder with a pointed base to accommodate the bottle upside down within the bottle holder housing. The infusion line is connected to the inlet of the blood pump, the outlet of the blood pump or the outlet (blood side) of the dialyzer. The infusion line can also "pass through" the air bubble detector to sense if/when anticoagulant is drained or blocked.
在一个实施方案中，参照图4，顶部单元40l(其包括用户界面和控制器)具有与基部单元402相同的深度但是不同的长度和高度，基部单元402包括与秤集成的储液器。在本示例性实施方案中，顶部单元40l和底部单元402都具有在10至30英寸的范围内、更优选地约19英寸的深度D。下面同时参照图4和5，在本示例性实施方案中，顶部单元40l、50l具有在6至20英寸的范围内、更优选地约14英寸的长度Lt，而底部单元402、502具有在14至40英寸的范围内、更优选地27英寸的长度Lb。在本示例性实施方案中，顶部单元40l、50l具有在7至2l英寸的范围内、更优选地约14.5英寸的高度Ht，而底部单元402、502具有在3至11英寸的范围内、更优选地7英寸的高度Hb。In one embodiment, referring to FIG. 4, the top unit 401 (which includes the user interface and controls) has the same depth but a different length and height as the base unit 402, which includes the reservoir integrated with the scale. In this exemplary embodiment, both top unit 401 and bottom unit 402 have a depth D in the range of 10 to 30 inches, more preferably about 19 inches. 4 and 5 together, in this exemplary embodiment, the top unit 401, 501 has a length Lt in the range of 6 to 20 inches, more preferably about 14 inches, while the bottom unit 402, 502 has a length Lt in the range of 14 inches. A length Lb in the range of 40 inches, more preferably 27 inches. In this exemplary embodiment, the top unit 401, 501 has a height Ht in the range of 7 to 21 inches, more preferably about 14.5 inches, while the bottom unit 402, 502 has a height Ht in the range of 3 to 11 inches, more preferably about 14.5 inches. A height Hb of 7 inches is preferred.
如图5所示，基部单元402、502还可以由两个肩部504限定，每个从定位在中心的顶部单元50l的侧部沿着基部单元502的长度向外延伸。顶部单元优选地定位在基部单元502的中心，如在图4中由长度Lb测量。因此，肩部504可以被限定为具有在4英寸至10英寸的范围内、更优选地约7英寸的长度。唇部503从基部单元502的在其处肩部504物理地接触顶部单元50l的表面向上延伸，该唇部限定顶部单元50l在其上对准和放置的表面。唇部503围绕顶部单元50l的基部连续，具有与顶部单元50l相同的长度和深度，具有的高度被限定为Ht2和Ht之间的差。在一个实施方案中，唇部高度在0.1至3.5英寸的范围内，更优选地0.6英寸。系统的总体高度Ht3在10至35英寸的范围内，更优选地22英寸。As shown in FIG. 5 , the base unit 402 , 502 may also be defined by two shoulders 504 each extending outwardly along the length of the base unit 502 from the sides of a centrally positioned top unit 501 . The top unit is preferably positioned at the center of the base unit 502 as measured by length Lb in FIG. 4 . Accordingly, shoulder 504 may be defined to have a length in the range of 4 inches to 10 inches, more preferably about 7 inches. Extending upwardly from the surface of the base unit 502 where the shoulder 504 physically contacts the top unit 501 is a lip 503 that defines a surface upon which the top unit 501 is aligned and placed. The lip 503 is continuous around the base of the top unit 501, has the same length and depth as the top unit 501, with a height defined as the difference between Ht2 and Ht. In one embodiment, the lip height is in the range of 0.1 to 3.5 inches, more preferably 0.6 inches. The overall height Ht3 of the system is in the range of 10 to 35 inches, more preferably 22 inches.
限定顶部单元50l和基部单元502的外部外壳结构可以表征为矩形平行六面体、长方体或盒子，每个都具有四个侧部、一个顶部和一个底部。在示例性实施方案中，对于顶部单元50l和基部单元502二者来说，四个侧部中的两个(每个具有外部和内部表面)具有相同的高度、长度和深度，而顶部和底部结构(每个具有外部和内部表面)具有相同的高度、长度和深度。The outer housing structure defining the top unit 501 and the base unit 502 may be characterized as a rectangular parallelepiped, cuboid or box, each having four sides, a top and a bottom. In an exemplary embodiment, for both the top unit 501 and the base unit 502, two of the four sides (each having exterior and interior surfaces) have the same height, length and depth, while the top and bottom The structures (each with exterior and interior surfaces) have the same height, length and depth.
应当理解的是，在图l、2、3、4和5中示出的系统配置是示例性的并非限制性的。例如，如图3所示，顶部单元30l可以定位在基部单元302的一侧上(产生不对称的基部)，如与定位在基部单元302的顶部上相对于基部单元302的总体长度在中心相反(产生对称的基部)。虽然将顶部单元301放置到基部单元302的一侧具有将所有的管路连接部和消耗品放置在系统的同一侧上的优点，但是吸附剂盒317和透析器313没有必要挤在一起使机器更难以使用。It should be understood that the system configurations shown in Figures 1, 2, 3, 4 and 5 are exemplary and not limiting. For example, as shown in FIG. 3 , top unit 301 may be positioned on one side of base unit 302 (creating an asymmetrical base), as opposed to being positioned on top of base unit 302 centrally relative to the overall length of base unit 302. (creating a symmetrical base). While placing the top unit 301 to one side of the base unit 302 has the advantage of placing all plumbing connections and consumables on the same side of the system, the sorbent cartridge 317 and dialyzer 313 do not necessarily crowd together to make the machine more difficult to use.
参照图6，在另一个实施方案中，顶部单元60l(包括用户界面和控制器)具有与基部单元602相同的深度和长度但是不同的高度，基部单元602包括与秤604集成的储液器。在本示例性实施方案中，顶部单元60l和底部单元602都具有在16.0至20.0英寸的范围内、更优选地小于24英寸并且约17.0英寸的深度。在本示例性实施方案中，顶部单元60l和底部单元602具有在10.0至15.0英寸的范围内、更优选地小于18英寸或约13.0英寸的长度Lt。在本示例性实施方案中，顶部单元60l具有在10.0至14.0英寸的范围内、更优选地小于17英寸并且约12.0英寸的高度Ht，而底部单元602具有在9.0至11.0英寸的范围内、更优选地小于13英寸并且约9.5英寸的高度Hb。两个单元合在一起的总高度由Ht3表示。基部单元602和顶部单元60l因此具有相同的表面面积但是不同的高度。应当理解的是，基部单元602和顶部单元60l也可以具有相同的表面面积和相同的高度。Referring to FIG. 6 , in another embodiment, a top unit 601 (including a user interface and controls) has the same depth and length but a different height as a base unit 602 that includes a reservoir integrated with a scale 604 . In this exemplary embodiment, both top unit 601 and bottom unit 602 have a depth in the range of 16.0 to 20.0 inches, more preferably less than 24 inches and about 17.0 inches. In this exemplary embodiment, top unit 601 and bottom unit 602 have a length Lt in the range of 10.0 to 15.0 inches, more preferably less than 18 inches or about 13.0 inches. In this exemplary embodiment, top unit 601 has a height Ht in the range of 10.0 to 14.0 inches, more preferably less than 17 inches and about 12.0 inches, while bottom unit 602 has a height Ht in the range of 9.0 to 11.0 inches, more preferably A height Hb of less than 13 inches and about 9.5 inches is preferred. The total height of the two units taken together is indicated by Ht3. The base unit 602 and the top unit 601 thus have the same surface area but different heights. It should be understood that the base unit 602 and the top unit 601 may also have the same surface area and the same height.
从基部单元602下方延伸出来的是平坦化的侧翼610，其包括用于附接吸附剂盒和输注液容器615的连接器。侧翼610的表面可以包括可以电子地感测水分的存在和/或可以倾斜以将任何水分引导至在策略上所放置的传感器的膜。Extending from below the base unit 602 are flattened side wings 610 that include connectors for attaching a sorbent cartridge and an infusion fluid container 615 . The surface of the flanks 610 may include a membrane that may electronically sense the presence of moisture and/or may be sloped to direct any moisture to strategically placed sensors.
参照图7，在另一个实施方案中，顶部单元70l可以与扩展坞(dockingstation)705物理地连接，其与位于远程的基部单元702电子地并且流体地连接715。虽然位于基部单元702中的储液器将仍然必须与控制器70l流体连通，但是扩展坞705的使用将允许改变正在被使用的储液器系统的大小的更大灵活性，由此允许一个控制器设计在多重的使用方案下得到实施或用于更宽范围的患者，例如小的患者与大的患者。Referring to FIG. 7 , in another embodiment, a top unit 701 may be physically connected to a docking station 705 , which is electronically and fluidly connected 715 to a remotely located base unit 702 . While the reservoir located in the base unit 702 will still have to be in fluid communication with the controller 701, the use of the docking station 705 will allow greater flexibility in changing the size of the reservoir system being used, thereby allowing a control The device design is implemented under multiple usage scenarios or for a wider range of patients, such as small patients versus large patients.
参照图8，在另一个实施方案中，便携式透析系统800合并具有下组件802的上子系统(泵送和控制单元)80l，如之前所描述。系统800的下部分802包括独立悬挂的透析液袋805。也就是说，透析液袋805不作为下组件802的一部分被结合，如在之前公开的实施方案中。此外，下组件802被设计成使得其结合有被集成到悬挂独立的透析液袋805的结构810中的称重机构。这种布置在透析系统配置成在血液滤过模式下操作时是合适的，因为在血液滤过模式下不需要在基于吸附剂的透析中使用的各种传感器，例如氨、pH和钠传感器；因此可以移除整个储液器组件模块，并且系统800可以通过使用透析液袋805而被简单地操作。下子系统802的模块化且紧凑的设计使其很容易移除，并且通过取走不必需的部件来简化在血液滤过模式下操作的系统。这是将在血液透析模式期间使用的透析液回路的主要部件集成到下基部单元802中的另一个优点。Referring to Figure 8, in another embodiment, a portable dialysis system 800 incorporates an upper subsystem (pumping and control unit) 801 with a lower assembly 802, as previously described. Lower portion 802 of system 800 includes independently suspended dialysate bags 805 . That is, the dialysate bag 805 is not incorporated as part of the lower assembly 802, as in previously disclosed embodiments. Furthermore, the lower assembly 802 is designed such that it incorporates a weighing mechanism integrated into the structure 810 from which the individual dialysate bags 805 are suspended. This arrangement is suitable when the dialysis system is configured to operate in a hemofiltration mode, since the various sensors used in sorbent-based dialysis, such as ammonia, pH and sodium sensors, are not required in the hemofiltration mode; The entire reservoir assembly module can thus be removed and the system 800 can be operated simply by using the dialysate bag 805 . The modular and compact design of the lower subsystem 802 allows for easy removal and simplifies the system operating in hemofiltration mode by removing unnecessary components. This is another advantage of integrating into the lower base unit 802 the main components of the dialysate circuit used during the hemodialysis mode.
本发明的透析系统实现表示相对于现有技术具有很大改进的功能及操作参数。参照在图l至6中示出的实施方案，顶部单元在约20—40镑的范围内并且更特别的是30镑，且底部单元在约15—30镑的范围内并且更特别的是22镑，从而比现有技术系统更轻。顶部单元在约l至4立方英尺的范围内并且更特别的是2.3立方英尺，且底部单元在约l至4立方英尺的范围内并且更特别的是2.8立方英尺，从而具有比现有技术系统更小的体积。The dialysis system implementation of the present invention represents greatly improved functionality and operating parameters over the prior art. Referring to the embodiment shown in FIGS. 1 to 6, the top unit is in the range of about 20-40 pounds and more particularly 30 pounds, and the bottom unit is in the range of about 15-30 pounds and more particularly 22 pounds. pounds and thus lighter than prior art systems. The top unit is in the range of about 1 to 4 cubic feet and more specifically 2.3 cubic feet, and the bottom unit is in the range of about 1 to 4 cubic feet and more specifically 2.8 cubic feet, thereby having a higher Smaller size.
此外，透析系统使用比现有技术系统更少的水。尽管常规系统每次治疗使用约120升，但是在一个实施方案中，本系统使用3至8升之间，并且更特别地在5至6升之间。此外，系统不需要家庭排水、供给连接或分离的出口来处理过量的水。Additionally, the dialysis system uses less water than prior art systems. While conventional systems use about 120 liters per treatment, in one embodiment the present system uses between 3 and 8 liters, and more specifically between 5 and 6 liters. Additionally, the system does not require household drains, supply connections, or separate outlets to handle excess water.
此外，系统设计更加紧凑，具有低功率要求(峰值仅为300W，操作期间为50至100W)、没有为了预充或行进所需要的分离的流体袋，并具有集成的泵。该装置使用20—600Qb(ml/min)的血液流量范围、50—500Qd(ml/min)的透析液流量操作。体积精确度同样精确到小于+/-30ml/小时。In addition, the system design is more compact, with low power requirements (only 300W peak, 50 to 100W during operation), no separate fluid bags required for priming or travel, and an integrated pump. The device operates using a blood flow range of 20-600 Qb (ml/min), a dialysate flow of 50-500 Qd (ml/min). Volumetric accuracy is also accurate to less than +/- 30ml/hour.
如图2所示，透析系统是模块化的。在一个实施方案中，顶部单元20l可以与底部单元202物理地分离。顶部单元20l包含集成地形成到独立外壳中的系统的主要电子部件，包括图形用户界面、控制器和泵。又大又笨重的底部单元202包含储液器222。系统电子部件与储液器的分离允许便携式透析系统被分离成多个单元用于安装、维护和行进，其中每个子单元很容易被操纵、包装和携带。设计特别地控制部件的大小以用于通过UPS或其他门转运至门携带者。其还提供产品生长的灵活性。例如，如果对控制器单元或单独地对储液器进行改进(例如减少流体体积或体积秤测量的改变)，则现有的顾客仅需要升级两个部件零件中的一个，而不是二者。同样，如果两个部件中的仅一个出现故障(例如泵烧坏了)，则顾客仅需要提交一个用于修理或购买两个部件中的一个。As shown in Figure 2, the dialysis system is modular. In one embodiment, the top unit 201 may be physically separate from the bottom unit 202 . The head unit 201 contains the main electronic components of the system, including the graphical user interface, controller and pump, integrally formed into a separate housing. The large and bulky bottom unit 202 contains a reservoir 222 . Separation of the system electronics from the reservoir allows the portable dialysis system to be separated into multiple units for installation, maintenance and travel, where each subunit is easily manipulated, packaged and carried. Design specifically sized components for transport to door carriers via UPS or other doors. It also provides flexibility in product growth. For example, if improvements are made to the controller unit or to the reservoir alone (such as a reduction in fluid volume or a change in volume scale measurement), existing customers only need to upgrade one of the two component parts, but not both. Likewise, if only one of the two parts fails (eg, the pump burns out), the customer only needs to submit one for repair or buy one of the two parts.
为了使上文描述的模块性成为可能，本发明的实施方案采用闩锁机构，闩锁机构在第一配置中将底部单元202牢固地附接到顶部单元20l，并且可以被操纵成将底部单元202从顶部单元20l可移除地拆卸。即使两个系统可以不使用闩锁而被简单地堆叠在彼此的顶部，但是闩锁的存在和使用降低了意外断开的可能性。此外，当被闩锁在一起时，装置更容易运动。闩锁机构优选地不使用任何工具，并且通过使用在顶部单元的基部和底部单元的顶部表面上存在的凸/凹匹配连接而得以简单地实现。进一步优选地，闩锁机构被设计成确保顶部和底部单元之间的牢固对准，由此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被暴露的电子连接器，如下文进一步描述)，其在单元被合适地对准时自动地接触并且完成动力电路。这允许使用单一的电源和简单的连接/断开。To enable the modularity described above, embodiments of the present invention employ a latch mechanism that, in a first configuration, securely attaches the bottom unit 202 to the top unit 201 and can be manipulated to attach the bottom unit 202 is removably detachable from top unit 201. Even though two systems could simply be stacked on top of each other without the use of latches, the presence and use of latches reduces the likelihood of accidental disconnection. Additionally, when latched together, the devices are easier to move. The latching mechanism preferably does not use any tools and is simply achieved by using a male/female mating connection present on the base of the top unit and the top surface of the bottom unit. It is further preferred that the latch mechanism is designed to ensure a secure alignment between the top and bottom units, thereby enabling access to electronic components (such as exposed electrical connectors on the bottom of the top unit and on the top of the bottom unit, As described further below), which automatically contacts and completes the power circuit when the unit is properly aligned. This allows for a single power supply and simple connect/disconnect.
参照图9，底部单元902具有四个侧部905a、905b、905c、905d、一个基部、一个顶部表面906和经过第一侧部905d可到达的储液器922。底部单元902还包括在其顶部表面906上的多个闩锁匹配结构920a、920b。在一个实施方案中，本发明包括两个闩锁匹配结构920a、920b，它们相对于底部单元902的长度被中心定位成确保均匀的重量分布。第一闩锁匹配结构920a优选地定位在如从侧部905d测量的等于底部单元902的宽度的三分之一的距离处。第二闩锁匹配结构920b优选地定位在如从侧部905b测量的等于底部单元902的宽度的三分之一的距离处。Referring to Figure 9, the bottom unit 902 has four sides 905a, 905b, 905c, 905d, a base, a top surface 906 and a reservoir 922 accessible through the first side 905d. The bottom unit 902 also includes a plurality of latch mating structures 920a, 920b on its top surface 906 . In one embodiment, the present invention includes two latch mating structures 920a, 920b that are centrally positioned relative to the length of the bottom unit 902 to ensure even weight distribution. The first latch mating structure 920a is preferably positioned at a distance equal to one third of the width of the bottom unit 902 as measured from the side 905d. The second latch mating structure 920b is preferably positioned at a distance equal to one third of the width of the bottom unit 902 as measured from the side 905b.
如图10所示，闩锁机构包括金属框架1001，其通过使用例如螺栓、螺钉或其他的紧固件1002被牢固地紧固到底部单元l005的顶部表面。框架l001支撑可以柔性地插入相应的闩锁中并且可从其拆卸的突出部或细长构件1003。As shown in Figure 10, the latch mechanism comprises a metal frame 1001 which is securely fastened to the top surface of the bottom unit 1005 using fasteners 1002 such as bolts, screws or others. The frame 1001 supports a protrusion or elongate member 1003 that can be flexibly inserted into and detached from a corresponding latch.
为了将底部单元牢固且可拆卸地附接到顶部单元，顶部单元包括互补的机械滑动闩锁，其被牢固地附接到顶部单元的基部。在一个实施方案中，顶部单元的基部包括第一闩锁，其优选地相对于顶部单元的长度定位在顶部单元的中心，并且处于如从第一侧测量的等于顶部单元的宽度的三分之一的距离处。基部还包括第二闩锁，其优选地相对于顶部单元的长度定位在顶部单元的中心，并且处于如从与第一侧相反且平行的第二侧测量的等于顶部单元的宽度的三分之一的距离处。In order to securely and detachably attach the bottom unit to the top unit, the top unit includes complementary mechanical slide latches which are securely attached to the base of the top unit. In one embodiment, the base of the top unit comprises a first latch, preferably positioned in the center of the top unit relative to the length of the top unit, and at a position equal to one third of the width of the top unit as measured from the first side at a distance of one. The base also includes a second latch preferably positioned at the center of the top unit relative to the length of the top unit and at a position equal to one third of the width of the top unit as measured from a second side opposite and parallel to the first side at a distance of one.
如图11所示，顶部单元包括具有滑动的金属平坦基部1120的闩锁1100。轨道1130与顶部单元的底部表面可滑动地接合，顶部单元的底部表面具有匹配构件以将轨道1130保持就位。闩锁1100具有两个闩锁凸台1115，它们适于滑入和滑出物理地附接到基部单元顶部表面的匹配结构。As shown in FIG. 11 , the top unit includes a latch 1100 with a metal flat base 1120 that slides. The track 1130 is slidably engaged with the bottom surface of the top unit, which has mating members to hold the track 1130 in place. The latch 1100 has two latch bosses 1115 adapted to slide in and out of mating structures physically attached to the top surface of the base unit.
附接到顶部单元的闩锁1100与底部单元906的顶部表面上的闩锁匹配结构920a、920b匹配。在操作中，当滑动闩锁1100处于第一位置时，顶部单元实际上将不在基部单元的顶部上配合或与基部单元对准，因为滑动闩锁1100将不会恰当地与闩锁匹配结构920a、920b物理地匹配。为了准备顶部单元牢固放置到基部单元906的顶部表面上，滑动闩锁在定位在顶部单元的底部上的构件保持结构内移动并且被置于第二位置。在第二位置，闩锁1111的把手将突出，从而移动凸台1115远离闩锁匹配结构920a、920b并且允许顶部单元正确地坐落在基部单元上。The latch 1100 attached to the top unit mates with the latch mating structures 920a, 920b on the top surface of the bottom unit 906 . In operation, when the sliding latch 1100 is in the first position, the top unit will not actually fit over or align with the base unit on top of the base unit because the sliding latch 1100 will not properly mate with the latch structure 920a , 920b are physically matched. To prepare the top unit for secure placement onto the top surface of the base unit 906, the slide latch is moved within the component retention structure positioned on the bottom of the top unit and placed in a second position. In the second position, the handle of the latch 1111 will protrude, thereby moving the boss 1115 away from the latch mating structures 920a, 920b and allowing the top unit to sit properly on the base unit.
参照图12和13，借助在顶部单元130l的底部上的四个小的橡胶足部或立足垫1340，具有滑动闩锁1380的顶部单元130l与底部单元1202对准，四个小的橡胶足部或立足垫1340配置成或适于紧密且牢固地装配到位于紧邻底部单元1202的顶部上的每个拐角处的四个空腔或凹坑1230中。此外，顶部单元130l可以使用在基部单元1202的顶部表面上的对准销1260或突出部而与底部单元1202精确地对准，对准销1260或突出部配置成或适于牢固且紧密地装配到在顶部单元130l的底部表面上的相应空腔1390中。底部单元还具有闩锁匹配结构1263，如上文所述。Referring to Figures 12 and 13, top unit 1301 with sliding latch 1380 is aligned with bottom unit 1202 by means of four small rubber feet or footing pads 1340 on the bottom of top unit 1301, four small rubber feet Or footing pads 1340 are configured or adapted to fit snugly and securely into four cavities or pockets 1230 located immediately adjacent each corner on the top of bottom unit 1202 . Additionally, the top unit 1301 can be precisely aligned with the bottom unit 1202 using alignment pins 1260 or protrusions on the top surface of the base unit 1202 that are configured or adapted to fit securely and tightly. into corresponding cavities 1390 on the bottom surface of top unit 130l. The bottom unit also has a latch mating structure 1263, as described above.
将橡胶立足部1340对准到空腔1230中以及将销1260对准到空腔1390中确保顶部单元130l上的闩锁1380可以被很容易地对准和闩锁至闩锁匹配结构1263，而没有过度的试验和错误。一旦对准，闩锁1380就通过将闩锁1380滑动到闩锁匹配结构1263中而与闩锁匹配结构1263匹配，从而在这两个单元之间产生紧配合。返回参照图9和11，为了解闩锁，闩锁把手1111被拉动或者以其他方式操纵，从而将凸台1115从基部单元凹槽920a、920b释放，并且允许顶部上单元从底部下单元抬升。Aligning the rubber feet 1340 into the cavities 1230 and the pins 1260 into the cavities 1390 ensures that the latches 1380 on the top unit 1301 can be easily aligned and latched to the latch mating structure 1263, while No undue trial and error. Once aligned, the latch 1380 mates with the latch mating structure 1263 by sliding the latch 1380 into the latch mating structure 1263, creating a tight fit between the two units. Referring back to FIGS. 9 and 11 , to unlock the latch, the latch handle 1111 is pulled or otherwise manipulated, releasing the bosses 1115 from the base unit grooves 920a, 920b and allowing the top upper unit to be lifted from the bottom lower unit.
此外，为了使上文描述的模块性成为可能，本发明的实施方案还采用电和数据通信连接机构，其在第一配置中安全地建立在底部单元和顶部单元之间的电连通和/或数据通信连接，并且在第二配置中终结在底部单元和顶部单元之间的电连通和/或数据通信连接。Furthermore, to enable the modularity described above, embodiments of the present invention also employ electrical and data communication connection mechanisms that securely establish electrical communication between the bottom unit and the top unit in the first configuration and/or data communication connection, and terminates the electrical and/or data communication connection between the bottom unit and the top unit in the second configuration.
参照图14，顶部和底部单元之间的电连接在顶部单元被放置在底部单元上时得以产生。这些连接通过非接触红外通信端口1403和推销功率端口1404作出，它们被一体地形成到板1402中并且通过使用紧固件140l而被牢固地附接到底部单元1405的顶部表面。应当理解的是，顶部单元的底部表面然后将包括与推销合适对准的电接触垫。应当进一步理解的是，推销和接触垫的位置可以颠倒，从而将推销放置在顶部单元的底部表面上并且将接触垫放置在底部单元的顶部表面上。Referring to Figure 14, electrical connections between the top and bottom units are made when the top unit is placed over the bottom unit. These connections are made through a contactless infrared communication port 1403 and a push-out power port 1404, which are integrally formed into the plate 1402 and securely attached to the top surface of the bottom unit 1405 using fasteners 1401. It should be understood that the bottom surface of the top unit will then include electrical contact pads in proper alignment with the push pins. It should further be understood that the positions of the push pins and contact pads may be reversed so that the push pins are placed on the bottom surface of the top unit and the contact pads are placed on the top surface of the bottom unit.
在一个实施方案中，通过将六个被弹簧加载的引脚置于与集成到顶部单元的底部表面中的接触垫的电接触而形成高电流功率连接。三个引脚用于+24伏DC电流并且三个引脚用于接地。在一个实施方案中，引脚或探针具有以下的特性：a)0.175英寸的最小中心，b)15安培(连续的)的电流额定，c)在0.06英寸至0.067英寸行程的在6.2oz至9.0oz范围内的弹簧力，d)小于10mΩ的典型电阻，e)在0.09至0.1英寸范围内的最大行程，f)在0.06至0.067英寸范围内的工作行程，g)由镍/银制造并且镀金的圆筒，h)不锈钢弹簧(可选地镀金)，i)由全硬铍铜制造并且镀金的柱塞，以及j)可选地不锈钢偏置球。引脚的弹簧力通过吸收弯曲或其他扭弯而有助于防止断裂。应当理解的是，术语电引脚代表任何能够传输电功率的突出部，电接触垫代表任何能够接收电引脚的表面。In one embodiment, the high current power connections are made by placing six spring loaded pins in electrical contact with contact pads integrated into the bottom surface of the top unit. Three pins are for +24 volt DC current and three pins are for ground. In one embodiment, the pins or probes have the following characteristics: a) a minimum center of 0.175 inches, b) a current rating of 15 amps (continuous), c) a travel range of 6.2 oz to 0.067 in. Spring force in the 9.0oz range, d) typical resistance of less than 10mΩ, e) maximum travel in the range of 0.09 to 0.1 inches, f) working travel in the range of 0.06 to 0.067 inches, g) manufactured from nickel/silver and Gold plated cylinder, h) stainless steel spring (optionally gold plated), i) plunger fabricated from full hard beryllium copper and gold plated, and j) optionally stainless steel bias ball. The spring force of the pins helps prevent breakage by absorbing bends or other twists. It should be understood that the term electrical pin refers to any protrusion capable of transmitting electrical power, and an electrical contact pad refers to any surface capable of receiving an electrical pin.
非接触红外通信端口1403采用两个LED发射器和两个LED接收器，它们与在顶部单元的底部表面上的两个LED发射器和两个LED接收器对准并且与它们通信。传输端口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二者上，四个LED单元被分成两对，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)。当顶部和底部单元适当对准时，这些端口被置于数据通信。The non-contact infrared communication port 1403 employs two LED emitters and two LED receivers that align with and communicate with the two LED emitters and two LED receivers on the bottom surface of the top unit. The distance between the transmit port and receive port is less than 0.3 inches. On both the top surface of the bottom unit and the bottom surface of the top unit, the four LED units are divided into two pairs, a control pair (comprising an emitter and a receiver) and a safety pair (comprising an emitter and a receiver) device). These ports are placed in data communication when the top and bottom units are properly aligned.
在一个实施方案中，LED发射器是由GaAlAs双异质技术制造的870nm高速红外发射二极管。LED发射器是具有以下的特性的高速二极管：a)超高的辐射功率，b)低正向电压，c)适于高脉冲电流操作，d)约17度的半强度的角，e)约870nm的峰值波长，f)约5V的反向电压，g)约100mA的正向电流，h)约200mA的峰值正向电流，i)约0.8A的浪涌正向电流，j)约190mW的功率耗散，k)约l00摄氏度的结温，以及l)-40至85摄氏度的操作温度范围。应当理解的是，非接触红外通信端口可以以任何功能的方式分布在底部单元的顶部表面或顶部单元的底部表面上。应当进一步理解的是，任何其他的本领域技术人员已知的通信端口或结构可以在本文中实施。In one embodiment, the LED emitter is an 870nm high speed infrared emitting diode fabricated by GaAlAs double hetero technology. LED emitters are high-speed diodes with the following characteristics: a) ultra-high radiant power, b) low forward voltage, c) suitable for high pulse current operation, d) an angle at half intensity of about 17 degrees, e) about 870nm peak wavelength, f) about 5V reverse voltage, g) about 100mA forward current, h) about 200mA peak forward current, i) about 0.8A surge forward current, j) about 190mW power dissipation, k) a junction temperature of about 100 degrees Celsius, and l) an operating temperature range of -40 to 85 degrees Celsius. It should be understood that the contactless infrared communication ports may be distributed in any functional manner on the top surface of the bottom unit or the bottom surface of the top unit. It should be further understood that any other communication ports or structures known to those skilled in the art may be implemented herein.
在一个实施方案中，LED接收器是高速硅光电二极管，具有极快的响应时间、约0.25mm2的辐射敏感区域和约15度的半灵敏度的角度。接收器具有以下特征：a)约60V的反向电压，b)约75mW的功率耗散，c)约l00摄氏度的结温，d)-40至85摄氏度的操作温度范围，e)约lV的正向电压，f)60V的最小击穿电压，以及g)约1.8pF的二极管电容。In one embodiment, the LED receiver is a high speed silicon photodiode with an extremely fast response time, a radiation sensitive area of about 0.25mm2 and an angle of half sensitivity of about 15 degrees. The receiver has the following characteristics: a) a reverse voltage of about 60V, b) a power dissipation of about 75mW, c) a junction temperature of about 100 degrees Celsius, d) an operating temperature range of -40 to 85 degrees Celsius, e) a power dissipation of about 1V forward voltage, f) a minimum breakdown voltage of 60V, and g) a diode capacitance of about 1.8pF.
返回参照图l、2和3，在控制器单元20l的顶部的是把手211、311和以可使用的托架112、212的形式的工作空间。位于系统上部泵送部分上的把手直接连接到系统的内结构或框架，并且不简单地是外部塑料模制、外壳或围绕顶部单元10l、20l的表皮的延伸部。至系统内部框架的直接连接允许使用把手将系统以安全并且可靠处理负载的形式再定位系统，特别是当仪器采用六升水(加入约40lbs)进行操作时。Referring back to Figures 1, 2 and 3, on top of the controller unit 20l are handles 211, 311 and a workspace in the form of a bracket 112, 212 that can be used. The handles on the upper pumping portion of the system are directly connected to the inner structure or frame of the system and are not simply an extension of the outer plastic molding, shell or skin surrounding the top unit 101, 201. The direct connection to the internal frame of the system allows the handle to be used to reposition the system in a manner that safely and reliably handles the load, especially when the instrument is operated with six liters of water (approximately 40 lbs added).
参照图15，在一个实施方案中，顶部单元150l包括内部金属壳体、框架或外壳1510，电子部件、控制器和其他顶部单元部件包含在其内或安装至其。内部壳体1510包括延伸至顶部单元150l的背部侧的水平突出臂1507。大致水平的顶部托架1505包括至少一个一体形成到顶部托架结构1505中的把手1520、基部支架1530和竖直臂1506，从而产生单一连续的金属或模制塑料件。基部支架1530牢固地附接到在顶部单元150l前部的内部壳体1510，并且竖直臂1506通过使用螺钉在点1508处被牢固地附接到突出臂1507。通过将托架1505和把手1520结构牢固地附接到顶部单元150l的内部壳体1510，避免了通常会通过将大重量的负载放置在把手和顶部单元的外部或外侧外壳之间的连接点处而发生的潜在破坏或断裂。Referring to FIG. 15 , in one embodiment, the top unit 1501 includes an internal metal housing, frame or housing 1510 within which or mounted to are electronics, controls and other top unit components. The inner housing 1510 includes a horizontally protruding arm 1507 extending to the back side of the top unit 1501. The generally horizontal top bracket 1505 includes at least one handle 1520, base bracket 1530, and vertical arms 1506 integrally formed into the top bracket structure 1505, resulting in a single continuous piece of metal or molded plastic. The base bracket 1530 is securely attached to the inner housing 1510 at the front of the top unit 1501 and the vertical arm 1506 is securely attached to the protruding arm 1507 at point 1508 using a screw. By structurally securely attaching the bracket 1505 and handle 1520 to the inner housing 1510 of the top unit 1501, the load that would normally be placed by placing a large weight at the connection point between the handle and the outer or outer shell of the top unit is avoided. resulting in potential damage or fracture.
金属门1562通过铰链1565也被附接到内部框架或壳体1510，其形成门110的内部框架，如图1所示。门1562牢固地附接到作为内部框架1510的一部分的板1561。结构1563和1572是保持和/或代表内部马达和滑轮组件的突出部的结构。从框架1510背部延伸的突出部1583用来连接各种电子部件，包括功率输入模块和USB连接l582。控制器单元的顶部或托架l505是平坦的并且具有侧壁，使其对于供给的存储或暂时的工作表面来说是理想的。Metal door 1562 is also attached by hinge 1565 to inner frame or housing 1510, which forms the inner frame of door 110, as shown in FIG. Door 1562 is securely attached to panel 1561 that is part of inner frame 1510 . Structures 1563 and 1572 are structures that hold and/or represent protrusions of the internal motor and pulley assembly. A tab 1583 extending from the back of the frame 1510 is used to connect various electronic components, including a power entry module and a USB connection 1582. The top or shelf 1505 of the controller unit is flat and has side walls, making it ideal for supply storage or a temporary work surface.
控制器单元160l的另一个结构特征在图16A中示出。优选地，单元160l具有内置暴露的读取器，例如条形码读取器或RFID标签读取器1605，其可以用于读取一次性部件上的代码或标签。操作性地，用户将优选地使用读取器扫描一次性部件上的全部代码/标签。通过初始GUI透析设置步骤可以进行对用户的提示，该初始GUI透析设置指示用户将每个一次性部件扫过读取器。Another structural feature of the controller unit 1601 is shown in FIG. 16A. Preferably, unit 1601 has a built-in exposed reader, such as a barcode reader or RFID tag reader 1605, which can be used to read codes or tags on disposable components. Operationally, the user will preferably use the reader to scan all codes/labels on the disposable. Prompting to the user may be done through an initial GUI dialysis setup step that instructs the user to swipe each disposable through the reader.
在这样做时，读取器获得关于一次性用品的识别信息，将该识别信息传输至存储在存储器中的内部表，将识别信息与内部表的内容比较，并且验证(或不验证)正确的一次性部件(特别是在透析液中使用的添加剂)是存在的。内部表的内容可以通过一次性用品的身份和量的手动输入或通过远程访问详细描述一次性用品的身份和量的处方而产生。该验证步骤具有至少两个益处。第一个是确保用户在其占有中具有所有的所需部件，第二个是确保正在使用正确的部件(不是伪造的或不合适的一次性用品)。该部件可用于使多种用户界面成为可能，如下文进一步描述。In doing so, the reader obtains identifying information about the disposable, transfers the identifying information to an internal table stored in memory, compares the identifying information with the contents of the internal table, and verifies (or does not verify) the correct Disposable parts (especially additives used in dialysate) exist. The contents of the internal table may be generated by manual entry of the identity and amount of the disposable or by remote access to a prescription detailing the identity and amount of the disposable. This verification step has at least two benefits. The first is to ensure that the user has all the required components in their possession, and the second is to ensure that the correct components are being used (not counterfeit or improper disposables). This component can be used to enable a variety of user interfaces, as described further below.
在另一个实施方案中，安装在顶部单元的侧部上的读取器1605是专业化的多功能红外照相机，其在一个模式中提供读取条形码的能力并且在另一个模式中探测输注液容器中的水平改变。照相机发射在液平面上反射的红外信号。被反射的信号由照相机的红外接收器接收，并且通过使用处理器得到处理来确定液面的弯液面的位置。在一个实施方案中，照相机可以确定并且监视液面的改变至0.02mm的分辨率。在一个实施方案中，照相机是1.3像素单晶片照相机模块，具有以下特性中的一个或多个：a)1280W×1024H有源像素，b)3.0μm像素尺寸，c)l/3英寸光学格式，d)RGBBayer颜色滤波阵列，e)集成10位ADC，f)集成数字图像处理功能，包括缺陷纠正、镜头阴影校正、图像缩放、去马赛克、锐化、伽玛校正和色彩空间转换，g)内嵌的照相机控制器，用于自动曝光控制、自动白平衡控制和背电平补偿，h)可编程帧速率和输出降额功能，i)达15fpsSXGA逐行扫描，j)低功率30fpsVGA逐行扫描，k)8位并行视频接口，1)双线串行控制接口，m)片上PLL，n)2.4至3.0V的模拟电源，o)分离的I/O电源，p)具有电源开关的集成功率管理，以及q)24针屏蔽插座选项。在一个实施方案中，照相机是由STMicroelectronics制造的1.3兆像素照相机，型号为VL6624/VS6624。In another embodiment, the reader 1605 mounted on the side of the top unit is a specialized multifunction infrared camera that provides the ability to read barcodes in one mode and detect infusion fluids in another mode. The level in the container changes. The camera emits an infrared signal that is reflected on the liquid level. The reflected signal is received by the camera's infrared receiver and processed using a processor to determine the position of the meniscus of the liquid surface. In one embodiment, the camera can determine and monitor changes in liquid level to a resolution of 0.02 mm. In one embodiment, the camera is a 1.3 pixel single-chip camera module having one or more of the following characteristics: a) 1280W x 1024H active pixels, b) 3.0 μm pixel size, c) 1/3 inch optical format, d) RGBBayer color filter array, e) integrated 10-bit ADC, f) integrated digital image processing functions, including defect correction, lens shading correction, image scaling, demosaicing, sharpening, gamma correction and color space conversion, g) internal Embedded camera controller for automatic exposure control, automatic white balance control and back level compensation, h) programmable frame rate and output derating function, i) up to 15fps SXGA progressive scan, j) low power 30fps VGA progressive scan , k) 8-bit parallel video interface, 1) two-wire serial control interface, m) on-chip PLL, n) 2.4 to 3.0V analog power supply, o) separate I/O power supply, p) integrated power with power switch management, and q) 24-pin shielded receptacle option. In one embodiment, the camera is a 1.3 megapixel camera manufactured by STMicroelectronics, model number VL6624/VS6624.
透析系统的顶部或底部单元同样优选地具有电子接口，例如以太网连接部或USB端口，以使得能够直接连接到网络，从而便于远程处方验证、遵守警惕性及其他的远程服务操作。USB端口允许直接连接到配件产品例如血压监护器或血细胞比容计/饱和监视器。接口被电子地隔离，由此确保患者的安全，而无论接口连接装置的品质。The top or bottom unit of the dialysis system also preferably has an electronic interface, such as an Ethernet connection or a USB port, to enable direct connection to a network to facilitate remote prescription verification, compliance vigilance, and other remote service operations. The USB port allows direct connection to accessory products such as blood pressure monitors or hematocrit/saturation monitors. The interface is electronically isolated, thereby ensuring patient safety regardless of the quality of the interface connection device.
顶部单元的前部具有向系统l00提供简单的用户界面的图形用户界面114。在家庭设置中，重要的是装置应当是容易使用的。最大的使用颜色和触摸屏理想地适于该应用。触摸屏允许多重的用户输入配置，提供多重的语言能力，并且可以在晚上被容易地看到(特别是具有亮度控制和夜视颜色)。The front of the top unit has a graphical user interface 114 that provides a simple user interface to the system 100. In a home setting it is important that the device should be easy to use. The maximum use of color and the touch screen are ideally suited for this application. The touch screen allows multiple user input configurations, provides multiple language capabilities, and can be easily seen at night (especially with brightness control and night vision colors).
GUI还包括的特征是用于在操作期间自动关闭、打开和锁定门。在一个实施方案中，GUI将门打开至第一闩锁位置，然后用户必须按下物理门打开按钮以完全地打开门。在另一个实施方案中，装置具有允许用户打开门的手动超越控制部(例如通过按下打开门按钮两次或使用额外的力)来手动地打开门。参照图16A，优选地，紧邻于GUI1630的是具有灯光视觉指示的单一机械按钮1610，其如果被激活的话则提供具有共同功能(例如停止系统)的中央停止按钮，而与操作的状态无关。The GUI also includes features for automatically closing, opening and locking the doors during operation. In one embodiment, the GUI opens the door to a first latched position, and then the user must press a physical door open button to fully open the door. In another embodiment, the device has a manual override that allows the user to open the door to open the door manually (eg, by pressing the door open button twice or using additional force). Referring to FIG. 16A , preferably immediately adjacent to the GUI 1630 is a single mechanical button 1610 with a lighted visual indication which, if activated, provides a central stop button with a common function (such as stopping the system), regardless of the state of operation.
为了提供进一步的固定和安全，系统1600控制基部单元1615中的储液器门1625的打开，而不需要独立于顶部单元160l的门控制系统的门控制器、按钮或机械系统。在一个实施方案中，通过物理地附接到、连接到顶部单元160l的前部门1635或以其他方式被顶部单元160l的前部门1635控制的突出部1620，物理地阻止储液器门1625打开。突出部1620可以从相对于顶部单元160l的任何方向在储液器门1625上延伸，该突出部用以提供对打开储液器门1625的物理障碍。因此，在本实施方案中，人们不能够在不首先解锁并且打开控制器门1635的情况下打开储液器门1625，控制器门由用户界面控制。To provide further security and security, the system 1600 controls the opening of the reservoir door 1625 in the base unit 1615 without requiring a door operator, button or mechanical system separate from the door control system of the top unit 1601. In one embodiment, the reservoir door 1625 is physically prevented from opening by a protrusion 1620 physically attached to, connected to, or otherwise controlled by the front door 1635 of the top unit 1601. A protrusion 1620 may extend over the reservoir door 1625 from any direction relative to the top unit 1601 , the protrusion serving to provide a physical barrier to opening the reservoir door 1625 . Thus, in this embodiment, one cannot open the reservoir door 1625 without first unlocking and opening the controller door 1635, which is controlled by the user interface.
在透析系统的一个实施方案的另一个视图中，如图16B所示，透析系统1600包括具有氨传感器1670、GUI1630及用于打开和关闭控制器门1635的单一机械按钮1610的控制器单元160l，以及具有储液器门1625和内置暴露的读取器例如条形码读取器或RFID标签读取器1605的基部单元1615，储液器门1625被突出部1620物理地阻止打开，突出部1620物理地附接到、连接到顶部单元1601的前部门1635或以其他方式被顶部单元160l的前部门1635控制。控制器单元160l和基部单元1615定位在单一连续的大致平面基部或分割的平面基部1645的顶部，该平面基部1645具有两个附接机构1675、1695。用于将吸附剂盒1680保持就位的第一附接机构1675定位成毗邻于用于将浓缩液罐1695保持就位的第二附接机构1695，在透析系统1600的同一个侧上。平面基部1645优选地包括滴水盘或其他的水分捕捉或传感表面。In another view of one embodiment of a dialysis system, as shown in Figure 16B, a dialysis system 1600 includes a controller unit 1601 having an ammonia sensor 1670, a GUI 1630, and a single mechanical button 1610 for opening and closing a controller door 1635, and a base unit 1615 with a reservoir door 1625 and a built-in exposed reader, such as a barcode reader or RFID tag reader 1605, the reservoir door 1625 being physically prevented from opening by a protrusion 1620, which physically Attached to, connected to, or otherwise controlled by the front door 1635 of the top unit 1601. The controller unit 1601 and base unit 1615 are positioned on top of a single continuous generally planar base or a segmented planar base 1645 having two attachment mechanisms 1675 , 1695 . The first attachment mechanism 1675 for holding the sorbent cartridge 1680 in place is located adjacent to the second attachment mechanism 1695 for holding the concentrate tank 1695 in place, on the same side of the dialysis system 1600 . The planar base 1645 preferably includes a drip pan or other moisture capturing or sensing surface.
参照图16C，控制器单元160l和基部单元1615以侧面示出。吸附剂盒1680由附接机构1675保持就位并且浓缩液罐1690由附接机构1695保持就位。吸附剂盒1680和浓缩液罐1690二者放置在平面表面例如滴水盘1668的顶部以确保所有的水分都被捕获。扫描器1605定位在基部单元1615的侧部上并且与浓缩液罐1690直接光学通信。流体从系统1600流至吸附剂盒1680并从其流动以及经由三个管状或流体节段164l、1642、1643从浓缩液罐1690流动。管子节段1642将浓缩液罐1690放置为通过浓缩液歧管端口与歧管流体连通。管子节段164l将吸附剂盒1680放置为通过吸附剂流出端口与歧管流体连通，从而将需要再生的透析液发送至吸附剂盒1680。管子节段1643将吸附剂盒1680放置为通过吸附剂流入端口与歧管流体连通，从而接收来自吸附剂盒1680的已再生的透析液。管子节段1643使用机构167l而可拆卸地附接成靠近氨传感器1670，机构167l例如为钩子、夹子、夹持器或其他的允许管子节段1643被容易拆卸并且放置为在与吸附剂盒1680相同的侧部上与定位在控制器单元l60l的侧部上的氨传感器1670紧密接触。在一个实施方案中，氨传感器1670包括光学传感器，该光学传感器使用比色测量方法来确定氨的存在以及这样的氨是否超出预定阈值。Referring to FIG. 16C , the controller unit 1601 and the base unit 1615 are shown in profile. Sorbent cartridge 1680 is held in place by attachment mechanism 1675 and concentrate tank 1690 is held in place by attachment mechanism 1695 . Both the sorbent cartridge 1680 and the concentrate tank 1690 are placed on top of a flat surface such as the drip pan 1668 to ensure that all moisture is captured. The scanner 1605 is positioned on the side of the base unit 1615 and is in direct optical communication with the concentrate tank 1690 . Fluid flows from system 1600 to and from sorbent cartridge 1680 and from concentrate tank 1690 via three tubular or fluid segments 1641 , 1642 , 1643 . Tube segment 1642 places concentrate tank 1690 in fluid communication with the manifold through the concentrate manifold port. Tubing segment 1641 places sorbent cartridge 1680 in fluid communication with the manifold through the sorbent outflow port, thereby sending dialysate requiring regeneration to sorbent cartridge 1680 . Tube segment 1643 places sorbent cartridge 1680 in fluid communication with the manifold through the sorbent inflow port, thereby receiving regenerated dialysate from sorbent cartridge 1680 . The tube segment 1643 is detachably attached in proximity to the ammonia sensor 1670 using a mechanism 1671 such as a hook, clip, clamp, or other that allows the tube segment 1643 to be easily detached and placed in place with the sorbent cartridge 1680 The same side is in close contact with the ammonia sensor 1670 positioned on the side of the controller unit 160l. In one embodiment, the ammonia sensor 1670 includes an optical sensor that uses a colorimetric measurement method to determine the presence of ammonia and whether such ammonia exceeds a predetermined threshold.
参照图l，储液器系统102具有门118，该门在被拉动并且不被任何突出部阻挡时将储液器122滑动出来或者以其他方式使储液器122是用户可到达的，以允许用户插入或改变用于透析的流体。储液器体积由秤系统监视。基于秤的流体天平604(在图6中并且更特别地在图17A和17B中描绘)与储液器一体地形成并且提供精确的流体移除数据并且使得能够精确地平衡计算，由此防止由流体不平衡所导致的低血压和其他疾病。将秤与储液器集成并且包封它们完全提供更强健的系统。Referring to FIG. 1 , the reservoir system 102 has a door 118 that, when pulled and not blocked by any protrusion, slides out or otherwise makes the reservoir 122 accessible to the user to allow The user inserts or changes the fluid used for dialysis. The reservoir volume is monitored by a scale system. A scale-based fluid balance 604 (depicted in FIG. 6 and more particularly in FIGS. 17A and 17B ) is integrally formed with the reservoir and provides accurate fluid removal data and enables accurate balance calculations, thereby preventing Hypotension and other disorders caused by fluid imbalances. Integrating the scale with the reservoir and encapsulating them all provides a more robust system.
参照图17A，示出了储液器系统的内结构l700。金属内部框架1720包括两个侧部172l、一个背部1722、一个面开放的前部1723和一个基部1724。示出的内结构或框架没有外部外壳，如示出为图l中的元件102。秤1718集成到储液器内结构l700中。秤1718的底表面1715包括金属表面或盘，金属表面或盘与秤1718的其余部分共同地通过四个挠曲部1705而从外部储液器外壳悬挂(在图l中示出为102)。优选地，加热垫位于秤的底部表面1715下方，例如能够导致温度增加并且将增加的温度作为热传导至表面1715的正方形、矩形、圆形或其他成形的表面。能够施加场并且使用该场的改变来测量电导的电导线圈1770被集成到基部表面1715中。因此，当储液器袋(未示出)放置在底表面1715上时，其可以被加热垫加热，并且因为其与线圈1770接触，所以可以监视其电导。Referring to Figure 17A, the internal structure 1700 of the reservoir system is shown. The metal inner frame 1720 includes two sides 1721 , a back 1722 , an open-faced front 1723 and a base 1724 . The inner structure or frame is shown without an outer shell, as shown as element 102 in FIG. 1 . The scale 1718 is integrated into the reservoir inner structure 1700. The bottom surface 1715 of the scale 1718 includes a metal surface or pan that, together with the rest of the scale 1718, is suspended from the external reservoir housing (shown as 102 in FIG. 1 ) by four flexures 1705. Preferably, a heating pad is located below the bottom surface 1715 of the scale, such as a square, rectangular, circular or other shaped surface capable of causing an increase in temperature and conducting the increased temperature as heat to the surface 1715 . A conductance coil 1770 capable of applying a field and using changes in the field to measure conductance is integrated into the base surface 1715 . Thus, when a reservoir bag (not shown) is placed on the bottom surface 1715, it can be heated by the heating pad, and since it is in contact with the coil 1770, its conductance can be monitored.
侧部172l的内表面包括多个轨道、细长构件或突出部1719，其用于固定、保持、包封或附接到储液器袋可以被附接到其的一次性储液器袋安装表面，例如塑料片1710。特别地，定位在表面1715上的储液器袋可以具有附接到被集成到片1710中的导管177l的出口。挠曲部l705安装在秤表面1718的四个拐角中的每个，其中每个都包括霍尔传感器和磁体。The inner surface of side portion 1721 includes a plurality of rails, elongate members or protrusions 1719 for securing, holding, enclosing or attaching to a disposable reservoir bag installation to which the reservoir bag may be attached. Surface, such as plastic sheet 1710. In particular, a reservoir bag positioned on surface 1715 may have an outlet attached to conduit 1771 integrated into sheet 1710 . Flexures 1705 are mounted to each of the four corners of scale face 1718, each of which includes a Hall sensor and magnet.
因此，在一个实施方案中，储液器子系统组件的部件包括但不限于透析液储液器，包括一次性储液器管线或袋，透析液加热器、透析液温度监视器、储液器称重系统，包括磁挠曲部和倾斜传感器、透析液氨浓度和pH传感器，包括一次性传感器元件和可反复使用的光学读取器，透析液电导传感器(非接触型)、以及湿度或泄漏传感器。Thus, in one embodiment, components of the reservoir subsystem assembly include, but are not limited to, dialysate reservoirs, including disposable reservoir lines or bags, dialysate heaters, dialysate temperature monitors, reservoir Weighing systems, including magnetic flexure and tilt sensors, dialysate ammonia concentration and pH sensors, including disposable sensor elements and reusable optical readers, dialysate conductivity sensors (non-contact), and humidity or leakage sensor.
本领域技术人员要理解的是，除了上文列出的传感器，透析液回路中的其他部件例如泵和传感器例如压力换能器也可以包括在储液器模块内。此外，各种传感器例如氨和pH传感器可以作为单个传感器集成到储液器模块中，或者作为包括所有传感器的单一“传感器子模块”。Those skilled in the art will appreciate that in addition to the sensors listed above, other components in the dialysate circuit such as pumps and sensors such as pressure transducers may also be included in the reservoir module. Additionally, various sensors such as ammonia and pH sensors can be integrated into the reservoir module as a single sensor, or as a single "sensor sub-module" that includes all sensors.
包括这些部件中的每个以使储液器组件模块特别地适用于再循环的基于吸附剂的透析系统的操作的形式被设计。此外，模块同样设计成使得在透析的其他形式例如单通血液滤过期间，模块的任何仅专用于基于吸附剂的透析的非必要元件可以被移除。Each of these components is included to make the reservoir assembly module particularly suitable for operation in recirculating sorbent-based dialysis systems. Furthermore, the module is also designed such that during other forms of dialysis, such as single-pass hemofiltration, any non-essential elements of the module dedicated only to sorbent-based dialysis can be removed.
图17B示出了储液器组件模块的一个实施方案，其中外皮或覆盖物是透明的，从而揭示内部布置。开口174l设置在储液器子系统模块1700的前部。储液器子组件的主要功能是包含透析液。开口174l允许一次性储液器袋被插入，一次性储液器袋可以是具有其中包含有透析液的常规IV袋。储液器模块l700还设置有在前部开口内部的用于包含储液器袋的盘1742。在一个实施方案中，平坦膜加热器和温度传感器二者都位于储液器盘1742的底部下方，并且帮助将透析液流体的温度保持在体温或接近于其。在一个实施方案中，透析液流体的温度可以由用户设置。Figure 17B shows an embodiment of a reservoir assembly module in which the skin or cover is transparent to reveal the internal arrangement. An opening 1741 is provided in the front of the reservoir subsystem module 1700 . The primary function of the reservoir subassembly is to contain dialysate. Opening 1741 allows insertion of a disposable reservoir bag, which may be a conventional IV bag with dialysate contained therein. The reservoir module 1700 is also provided with a tray 1742 inside the front opening for containing a reservoir bag. In one embodiment, both a flat film heater and a temperature sensor are located below the bottom of the reservoir pan 1742 and help maintain the temperature of the dialysate fluid at or close to body temperature. In one embodiment, the temperature of the dialysate fluid can be set by the user.
在一个实施方案中，储液器盘1742悬挂在秤机构1743中，如下文进一步描述。秤机构1743可以用于在开始透析之前精确地测量储液器袋中的透析液流体的重量，以及用于在透析期间保持回路中的透析液流体的体积平衡。In one embodiment, the reservoir pan 1742 is suspended from a scale mechanism 1743, as described further below. The scale mechanism 1743 can be used to accurately measure the weight of the dialysate fluid in the reservoir bag before initiating dialysis, as well as to maintain volumetric balance of the dialysate fluid in the circuit during dialysis.
在储液器组件模块1700的顶部，提供用于附接到透析系统泵送单元的特征1744，如之前所讨论。这些特征帮助储液器组件模块容易联接到泵送单元以及从其移除，该泵送单元在一个实施方案中可以安装在储液器组件的顶部。如下文进一步讨论，储液器组件模块的顶部还在该模块的任一侧上配备有排水沟1745。单个湿度传感器(未示出)设置在每个沟中。如本领域中已知，湿度传感器是一种光学装置，其基于通过空气和流体之间的折射率的差而导致的光进入与空气相对的流体中的增加的联接来感测水分。在排水沟1745中的湿度传感器在其安装在储液器组件的顶部上时保持追踪水分并且指示泵系统中的任何泄漏。通过将分离的湿度传感器布置在任一侧上的排水沟中，泄漏可以被定位并且关于任何可能需要的校正的特定引导可以被给予用户。On top of the reservoir assembly module 1700, features 1744 are provided for attachment to the pumping unit of the dialysis system, as previously discussed. These features help the reservoir assembly module to be easily coupled to and removed from the pumping unit, which in one embodiment may be mounted on top of the reservoir assembly. As discussed further below, the top of the reservoir assembly module is also provided with drains 1745 on either side of the module. A single moisture sensor (not shown) is positioned in each trench. As known in the art, a humidity sensor is an optical device that senses moisture based on the increased coupling of light into the fluid as opposed to the air caused by the difference in refractive index between the air and the fluid. A moisture sensor in the gutter 1745 keeps track of moisture when it is mounted on top of the reservoir assembly and indicates any leaks in the pump system. By placing separate wetness sensors in the gutter on either side, leaks can be located and specific guidance can be given to the user as to any corrections that may be required.
图17C示出了储液器组件模块的另一个视图，其中模块l700的外覆盖物被完全移除且某些内部部件表现为透明的。参照图17C，储液器盘1752设置有内部沟1753。沟1753还配备有湿度传感器，其位于透析液盘1752的正下方，挠曲部1755附接到湿度传感器，使得其可以感测储液器组件1700内部的泄漏。Figure 17C shows another view of the reservoir assembly module with the outer covering of the module 1700 completely removed and certain internal components appearing transparent. Referring to FIG. 17C , the reservoir pan 1752 is provided with internal grooves 1753 . The gutter 1753 is also equipped with a moisture sensor located directly below the dialysate pan 1752 to which the flexure 1755 is attached so that it can sense leaks inside the reservoir assembly 1700 .
储液器组件模块1700还包括传感器舱1754或子模块，其包括在同一个电路板上的各种传感器的集合。传感器板包括专门地关于基于吸附剂的透析的传感器，例如氨和pH传感器。在一个实施方案中，氨传感器包括一次性颜色敏感带条，其由响应于在透析液中存在的氨的水平而展示颜色的可见改变的材料制成。例如，指示物带条的颜色可以从蓝色逐渐改变成黄色，这取决于在该带条周围存在的氨水平。这样的视觉颜色指示使得更容易地保持追踪氨水平以及识别氨临界点是否发生。在一个实施方案中，为了更精确的评估氨指示物带条中的颜色改变，使用光学传感器。光学传感器同样位于传感器模块1754中，并且可以用于把一般的可见颜色读数转换为氨水平的精确指示。The reservoir assembly module 1700 also includes a sensor pod 1754 or sub-module that includes a collection of various sensors on the same circuit board. The sensor board includes sensors specific to sorbent-based dialysis, such as ammonia and pH sensors. In one embodiment, the ammonia sensor comprises a disposable color sensitive strip made of a material that exhibits a visible change in color in response to the level of ammonia present in the dialysate. For example, an indicator strip may gradually change color from blue to yellow, depending on the ammonia levels present around the strip. Such a visual color indication makes it easier to keep track of ammonia levels and to identify if an ammonia tipping point has occurred. In one embodiment, for a more accurate assessment of the color change in the ammonia indicator strip, an optical sensor is used. An optical sensor is also located in the sensor module 1754 and can be used to convert a generally visible color reading into an accurate indication of ammonia levels.
关于透析液钠浓度，应当理解的是，为了合适地进行肾脏透析以及导致穿过透析器的正确扩散，钠的浓度必须保持在某个范围内。确定流体的钠浓度的常规方法是测量流体的电导率和流体的温度，然后计算近似的钠浓度。以非接触方式测量透析液中的钠浓度的改进方法和系统使用内置于储液器盘1752底部的非接触式电导传感器。With regard to the dialysate sodium concentration, it is understood that in order to properly perform kidney dialysis and result in proper diffusion through the dialyzer, the sodium concentration must remain within a certain range. A conventional method of determining the sodium concentration of a fluid is to measure the conductivity of the fluid and the temperature of the fluid and then calculate an approximate sodium concentration. An improved method and system for measuring sodium concentration in dialysate in a non-contact manner uses a non-contact conductivity sensor built into the bottom of the reservoir pan 1752 .
在一个实施方案中，非接触电导传感器是利用线圈的电感装置。钠浓度的变化改变透析液溶液的电导，这进而改变线圈的阻抗。通过将电导传感器放置在储液器盘1752的底部且因此放置在储液器中透析液袋下方，大的表面区域被呈现给线圈。这确保测量的高精确度，此外不需要传感器与透析液流体物理接触。In one embodiment, the non-contact conductivity sensor is an inductive device utilizing a coil. The change in sodium concentration changes the conductance of the dialysate solution, which in turn changes the impedance of the coil. By placing the conductivity sensor at the bottom of the reservoir pan 1752 and thus below the dialysate bag in the reservoir, a large surface area is presented to the coil. This ensures a high degree of accuracy of the measurement and furthermore does not require the sensor to be in physical contact with the dialysate fluid.
参照图17D和17E，示出了非接触电导传感器的部件，包括在被适当激励时限定磁场的产生的具有n匝的线圈l788以及在由电阻元件Rs1786和Rp1785和电感器元件L1787限定的线圈被电地耦合于电容器178l时产生的所得到的谐振LCR振荡回路l780的图解。Referring to Figures 17D and 17E, there is shown the components of a non-contact conductivity sensor including a coil 1788 of n turns which, when properly energized, defines the generation of a magnetic field and is bounded by a coil defined by resistive elements Rs 1786 and Rp 1785 and an inductor element L 1787. A diagram of the resulting resonant LCR tank 1780 produced when electrically coupled to capacitor 1781.
线圈l788是与电容器178l共同用作能量储存装置的多层圆形扁平线圈。线圈l788具有损耗元件，其包括线圈线Rsl786和磁场损耗元件Rpl785的电阻、袋中流体的电导率。Coil 1788 is a multilayer circular flat coil used in conjunction with capacitor 1781 as an energy storage device. The coil 1788 has lossy elements including the resistance of the coil wire Rs1786 and the magnetic field lossy element Rp1785, the conductivity of the fluid in the bag.
线圈l788直径是渗透到流体中的磁场的函数。另一个针对流体渗透的因素是操作频率。低操作频率将更深地渗透到流体中，但是具有较低损耗的成本。较大的线圈将具有由尺寸公差导致的小的效果。定义方程提供如下：Coil 1788 diameter is a function of the magnetic field penetrating the fluid. Another factor for fluid penetration is the frequency of operation. Low operating frequencies will penetrate deeper into the fluid, but at the cost of lower losses. Larger coils will have small effects due to dimensional tolerances. The defining equations are provided as follows:
其中a＝线圈的以厘米计的平均半径，N＝匝数，b＝以厘米计的绕组厚度，h＝以厘米计的绕组高度。在一个实施方案中，线圈的半径在2至6英寸的范围内，且更特别地，2、3、4、5和6英寸以及在其之间的所有增量。where a = average radius of the coil in centimeters, N = number of turns, b = winding thickness in centimeters, h = winding height in centimeters. In one embodiment, the radius of the coils is in the range of 2 to 6 inches, and more particularly, 2, 3, 4, 5 and 6 inches and all increments therebetween.
参照回路l780，物理线圈l788由L1787和Rsl786表示，其中L是线圈的电感，Rs是线圈线的电阻。由L1787所产生的磁场的能量损耗由Rpl785表示。能量损耗Rp来源于紧邻于线圈l788的电导流体并且与其直接相关。因此，如果线圈l788放置在储液器盘中，集成到储液器盘的表面中，或者以其他方式放置在某距离处，使得由线圈l788产生的磁场可以受到袋内的透析液的存在或更具体地说是袋内的透析液的电导率影响，则袋的钠浓度以及因此电导的改变可以通过追踪由线圈l788产生的磁场的相应改变而得到监视和测量。Referring to loop 1780, the physical coil 1788 is represented by L1787 and Rs1786, where L is the inductance of the coil and Rs is the resistance of the coil wire. The energy loss of the magnetic field generated by L1787 is represented by Rp1785. The energy loss Rp originates from and is directly related to the electrically conductive fluid in close proximity to the coil 1788. Thus, if the coil 1788 is placed in the reservoir pan, integrated into the surface of the reservoir pan, or otherwise placed at a distance such that the magnetic field generated by the coil 1788 can be influenced by the presence of dialysate within the bag or Influenced more specifically by the conductivity of the dialysate within the bag, the bag's sodium concentration and thus the change in conductance can be monitored and measured by tracking the corresponding change in the magnetic field generated by the coil 1788.
回路l780使得能够精确测量由线圈l788产生的磁场的改变。当回路l780被以其谐振频率驱动时，能量在电感元件L1787和电容器178l之间来回传递。在谐振时，能量损耗与RS和RP的I2R损耗成比例。为了保持在整个C178l上的恒定AC电压，能量必须被供应至回路l780，且被供应的能量必须等于RPl785和RSl786的能量损耗。当L1787和C178l元件被放置在具有自动增益控制的皮尔斯振荡器中时，控制电压将与正在被感测的流体的电导率成比例，因为振荡器将需要更多的能量以伴以更高电阻场损耗来振荡，这主要是由于因钠浓度水平的改变而导致的透析液电导的改变。Loop 1780 enables precise measurement of changes in the magnetic field produced by coil 1788. When the loop I 780 is driven at its resonant frequency, energy is transferred back and forth between the inductive element L 1787 and the capacitor 178l. At resonance, the energy loss is proportional to the I2 R loss of RS and RP. To maintain a constant AC voltage across C1781, energy must be supplied to loop 1780, and the supplied energy must be equal to the energy losses of RP 1785 and RS 1786. When the L1787 and C178l elements are placed in a Pierce oscillator with automatic gain control, the control voltage will be proportional to the conductivity of the fluid being sensed, since the oscillator will require more power with higher resistance Field loss to oscillate, which is mainly due to changes in dialysate conductance due to changes in sodium concentration levels.
如之前参照图17B所提到，储液器盘被悬挂在秤机构中以用于精确地测量重量，并且用于保持在透析期间回路中的透析液流体的体积平衡。用于秤机构的悬挂点1755在图17C中示出。在一个实施方案中，提供四个悬挂点1755，其中的每个包括称重机构，如之前所描述。除四个悬挂点1755之外，储液器组件子系统l700还包括水平传感器。水平传感器允许精确重量的计算，即使储液器袋不是水平的。图17C还示出了在储液器组件模块l700的顶部上的引脚1756，其可用于提供至控制和/或泵送单元的电连接，如上文所提到，控制和/或泵送单元可以安装在储液器组件的顶部上。As previously mentioned with reference to Figure 17B, the reservoir pan is suspended in the scale mechanism for accurate weight measurement and for maintaining volumetric balance of the dialysate fluid in the circuit during dialysis. Suspension points 1755 for the scale mechanism are shown in Figure 17C. In one embodiment, four suspension points 1755 are provided, each of which includes a weighing mechanism, as previously described. In addition to the four suspension points 1755, the reservoir assembly subsystem 1700 also includes level sensors. A level sensor allows accurate weight calculations even when the reservoir bag is not level. Figure 17C also shows pins 1756 on the top of the reservoir assembly module 1700, which can be used to provide electrical connections to the control and/or pumping unit, as mentioned above, the control and/or pumping unit Can be mounted on top of the reservoir assembly.
参照图18，挠曲部1805包括多个附接点186l，挠曲部在该处被固定到外部储液器外壳。挠曲部还包括磁性体1862，例如两个磁体，以及霍尔传感器1864。挠曲部1805的基部1867附接到秤1718的顶部表面1715。当秤1718由于重量负载的施加而发生位移时(例如当储液器袋填充有透析液时袋压在表面1715上，从而向下拉动秤1718)，在一个端部连接到秤并且在另一个端部连接到外部外壳的挠曲部1805将弯曲，并且安装在挠曲部1805的一个端部上的磁体1862将借助于由磁性体1862产生的磁场的改变追踪该改变。霍尔传感器1864探测磁场强度的改变。本领域技术人员将理解如何把这种感测到的磁场改变转换为所施加的重量负载的度量。Referring to Figure 18, the flexure 1805 includes a plurality of attachment points 1861 where the flexure is secured to the outer reservoir housing. The flexure also includes a magnetic body 1862 , such as two magnets, and a Hall sensor 1864 . Base 1867 of flexure 1805 is attached to top surface 1715 of scale 1718 . When the scale 1718 is displaced due to the application of a weight load (such as when the reservoir bag is filled with dialysate, the bag presses against the surface 1715, thereby pulling the scale 1718 downward), connected to the scale at one end and at the other end. The flexure 1805 with the ends connected to the outer housing will bend and the magnet 1862 mounted on one end of the flexure 1805 will track the change by means of the change in the magnetic field produced by the magnet 1862 . Hall sensor 1864 detects changes in magnetic field strength. Those skilled in the art will understand how to convert this sensed change in magnetic field into a measure of the applied weight load.
前部门宽敞地(约l00度)打开，以加载一次性歧管。具有宽敞开口便于歧管加载和容易清洁机器的面和门的内侧。使门关闭并且覆盖装置的运动部分使其更加安全且更加强健，这对于家庭使用来说特别重要。此外，使前部门容纳显示器节约空间并且再加强重要的点，即装置将不被操作，除非一次性用品就位且门被关闭。门提供必要的闭合力于歧管及其泵节段上。门还在门的面中包含触摸屏、音频警报器和手动停止按钮。The front door opens wide (approximately 100 degrees) to load the disposable manifold. Features wide openings for manifold loading and easy cleaning of machine faces and inside doors. Having the door closed and covering the moving parts of the device makes it safer and more robust, which is especially important for domestic use. Furthermore, having the front door accommodate the monitor saves space and again reinforces the important point that the device will not be operated unless the disposable is in place and the door is closed. The doors provide the necessary closing force on the manifold and its pump segments. The door also contains a touch screen, an audio siren and a manual stop button in the face of the door.
在一个实施方案中，门由电动步进马达保持处于完全关闭位置。该马达通过用户界面操作，特别地在门已准备好被完全关闭或打开时通过用户按下按钮来操作。为了确保合适的压力由门和泵靴置于歧管结构上，优选的是具有门通过其被关闭并产生足够的关闭门力的电子机构。在一个实施方案中，产生90至110lbs的关闭门力。In one embodiment, the door is held in the fully closed position by an electric stepper motor. The motor is operated through the user interface, in particular by the user pressing a button when the door is ready to be fully closed or opened. In order to ensure proper pressure is placed on the manifold structure by the door and pump shoe, it is preferred to have an electronic mechanism by which the door is closed and generates sufficient closing door force. In one embodiment, a door closing force of 90 to 110 lbs is generated.
参照图19和20，示出了动力门关闭机构1900的一个实施方案。步进马达1906与导螺杆1916机械地接合，使得当被控制器致动时，步进马达1906使导螺杆1916转动，并且因此使杆1918、2018将起动力施加到钩子。位于构件2040下方的钩子用于闩锁到U形闩锁部2030上，并且在被拉动、转动或以其他方式朝向步进马达1906向内运动时，将U形闩锁部2030拉动为进一步关闭，从而施加必需的关闭门力。钩子与杆1918、2018物理地接合，并且可以被操纵成将U形闩锁部2030拉动为紧密关闭或者与U形闩锁部2030松弛地接合。动力关闭系统通过安装支架1905被安装并保持适当的定向。Referring to Figures 19 and 20, one embodiment of a power door closing mechanism 1900 is shown. Stepper motor 1906 is mechanically engaged with lead screw 1916 such that when actuated by the controller, stepper motor 1906 turns lead screw 1916 and thus causes rod 1918, 2018 to apply actuation force to the hook. Hooks located under member 2040 are used to latch onto U-latch 2030 and when pulled, turned or otherwise moved inwardly towards stepper motor 1906, pull U-latch 2030 further closed , thereby applying the necessary closing force. The hooks physically engage the rods 1918 , 2018 and can be manipulated to pull the U-latch 2030 tightly closed or engage the U-latch 2030 loosely. The powered shutdown system is mounted and held in proper orientation by mounting brackets 1905 .
参照图21，操作性地，用户将门关闭为足以把门上的U形闩锁部2110与在控制器单元的内部容积内侧的钩子2150接合。用户然后向便携式透析机指示关闭门的期望，优选地通过机械按钮或图形用户界面图标，其在被按下时将信号发送至控制器，控制器进而致动步进马达。步进马达将起动力施加到钩子2150，钩子2150然后把接合的U形闩锁部2110拉动为紧密关闭。在一个实施方案中，控制器监视正在由马达施加的扭力，并且当其达到预定极限时，停用步进马达。在另一个实施方案中，定位成紧邻导螺杆的霍耳装置感测导螺杆的延伸并且确定导螺杆的运动程度。如果导螺杆已经在产生更大关闭门力的方向上足够地运动，则霍尔传感器将信号传输至控制器以停用马达。可选地，传感器持续地传输指示导螺杆的延伸的信号，信号然后被控制器解释以确定是否已经施加足够的起动力以及是否应当停用步进马达。在任何这些实施方案中，如果马达超过扭矩，预设置的距离被超出，或者门在预定的时间内未达到其完全关闭位置，则控制器可以致动马达以停止和反转至完全打开的状态。控制器还可以使视觉和/或听觉警报器发出声音。Referring to Figure 21, operatively, the user closes the door sufficiently to engage the U-shaped latch portion 2110 on the door with the hook 2150 inside the interior volume of the controller unit. The user then indicates to the portable dialysis machine the desire to close the door, preferably via a mechanical button or graphical user interface icon, which when pressed sends a signal to the controller which in turn actuates the stepper motor. The stepper motor applies a starting force to the hook 2150 which then pulls the engaged U-shaped latch portion 2110 tightly closed. In one embodiment, the controller monitors the torque being applied by the motor, and when it reaches a predetermined limit, deactivates the stepper motor. In another embodiment, a Hall device positioned proximate to the lead screw senses the extension of the lead screw and determines the degree of movement of the lead screw. If the lead screw has moved enough in the direction that produces greater closing force, the Hall sensor transmits a signal to the controller to deactivate the motor. Optionally, the sensor continuously transmits a signal indicative of extension of the lead screw, which is then interpreted by the controller to determine whether sufficient starting force has been applied and whether the stepper motor should be deactivated. In any of these embodiments, if the motor is over torqued, a preset distance is exceeded, or the door does not reach its fully closed position within a predetermined time, the controller may actuate the motor to stop and reverse to the fully open state . The controller can also sound a visual and/or audible alarm.
当用户希望打开门时，机械按钮或图形用户界面图标被激活，将信号发送至控制器，控制器进而反向致动步进马达。钩子然后与U形闩锁部松弛地接合。机械释放按钮然后被按下来将松弛接合的钩子从U形闩锁部脱离。When the user wishes to open the door, a mechanical button or GUI icon is activated, sending a signal to the controller, which in turn actuates the stepper motor in reverse. The hook is then loosely engaged with the U-shaped latch. The mechanical release button is then depressed to disengage the loosely engaged hook from the U-shaped latch.
除了提供必需的关闭力之外，该动力门关闭机构具有多个重要的特征。第一，其被设计成避免障碍物被捕捉在门中并且经受强大的门关闭力。参照图21，凹陷到门2105中的用于接受歧管2130的区域被四个侧部边缘防护部2107围绕，如果堵塞物例如人的手指或未适当安装的一次性用品介于门2105和顶部单元的基部板之间的话，则该四个侧部边缘防护部2107防止门闩锁与顶部单元上的闩锁接收器接合。门2105包括金属壳体2125附接到的内表面2106。在一个实施方案中，门2105的内表面2106的顶部表面被牢固地附接到壳体2125的外表面。壳体2125大致为矩形并且限定具有四个侧部2107和基部2108的空腔，产生内部容积。空腔朝向透析系统2100的歧管结构2130打开，包围并且围绕歧管结构2130和防护部2140，防护部2140优选地是在歧管结构2130的顶部和侧部围绕该歧管结构的塑料护罩。泵靴2115和至少一个U形闩锁部2110附接到基部2108的表面，该U形闩锁部朝向背部板突出。钩子2150集成在防护部内并且从其延伸出，钩子2150配置成牢固地接合和脱离U形闩锁部2110。如果门被正确地关闭并且没有物体被捕捉在门和防护部之间，则U形闩锁部将被动力门锁定钩子机构机械地钩住。如果障碍物在门路径中，则金属壳体2125将不能延伸到顶部单元的内部容积中(以及包围防护部)，因此U形闩锁部将不能接合钩子，从而防止当障碍物就位时门的机械钩住和意外的动力关闭。In addition to providing the necessary closing force, the powered door closing mechanism has several important features. First, it is designed to avoid obstacles being caught in the door and subjected to strong door closing forces. Referring to Figure 21, the area recessed into the door 2105 for receiving the manifold 2130 is surrounded by four side edge guards 2107, should an obstruction such as a human finger or improperly installed disposable be between the door 2105 and the top Between the base panels of the unit, the four side edge guards 2107 prevent the door latch from engaging the latch receiver on the top unit. The door 2105 includes an inner surface 2106 to which a metal shell 2125 is attached. In one embodiment, the top surface of the inner surface 2106 of the door 2105 is securely attached to the outer surface of the housing 2125 . Housing 2125 is generally rectangular and defines a cavity with four sides 2107 and a base 2108 creating an interior volume. The cavity opens towards the manifold structure 2130 of the dialysis system 2100, encloses and surrounds the manifold structure 2130 and a shield 2140, which is preferably a plastic shroud surrounding the manifold structure 2130 at the top and sides . A pump shoe 2115 and at least one U-shaped latch 2110 are attached to the surface of the base 2108, the U-shaped latch protruding towards the back plate. Integrated within and extending from the guard portion is a hook 2150 configured to securely engage and disengage the U-shaped latch portion 2110 . If the door is properly closed and no objects are caught between the door and guard, the U-shaped latch will be mechanically hooked by the power door lock hook mechanism. If an obstruction is in the door path, the metal housing 2125 will not be able to extend into the interior volume of the top unit (and surround the guard), so the U-shaped latch will not be able to engage the hook, preventing the door from opening when the obstruction is in place. Mechanical hooking and unexpected power closing.
第二，机械按钮释放仅在动力关闭门力已经通过步进马达的反向运动而被消散时才能被致动，从而防止门的意外释放和快速打开。参照图19和20，当门被关闭和锁定时，按钮轴1907、2007上的轴环2050转动90度，移动推销远离动力门锁定钩子。轴环2050借助于杆192l而转动，杆192l在点2045连接到轴环并且与导螺杆1916机械接合。轴环2050被弹簧加载并且由小针螺线管锁定。如果在处于锁定位置时用户按下按钮，则按钮将运动到机器中，但是因为由轴环的转动所造成的位移，所以将不会脱离钩子，从而防止打开门。Second, the mechanical button release can only be actuated when the power to close the door force has been dissipated by the reverse motion of the stepper motor, thereby preventing accidental release and quick opening of the door. Referring to Figures 19 and 20, when the door is closed and locked, the collar 2050 on the button shaft 1907, 2007 is turned 90 degrees, moving the push pin away from the power door locking hook. The collar 2050 is rotated by means of a rod 1921 that is connected to the collar at point 2045 and mechanically engages the lead screw 1916 . The collar 2050 is spring loaded and locked by a small needle solenoid. If the user presses the button while in the locked position, the button will move into the machine, but because of the displacement caused by the rotation of the collar, will not disengage the hook, preventing the door from opening.
如果动力丧失或无意中止，则针螺线管将释放，从而允许轴环回转90度并且将推销置于适当对准。然后当用户按下按钮时，推销将接触动力门钩子并且释放门闩锁。该机构提供机械门释放的方便性和安全备份，而没有关注机械门释放可能意外地被激活以使门以巨大的力转动打开。应当理解的是，术语“钩子”或“闩锁”应被宽泛地定义为任何能够与另一个突出部或构件物理地或机械地接合的突出部或构件。应当进一步理解的是，术语“U形闩锁部”不是限制性的，并且可以使用如上文限定的任何闩锁机构或钩子机构。If power is lost or inadvertently aborted, the needle solenoid will release, allowing the collar to turn 90 degrees and put the push pin in proper alignment. Then when the user presses the button, the push pin will contact the power door hook and release the door latch. This mechanism provides the convenience and safety backup of a mechanical door release without concern that the mechanical door release may be accidentally activated to swing the door open with enormous force. It should be understood that the terms "hook" or "latch" should be broadly defined as any protrusion or member capable of physically or mechanically engaging another protrusion or member. It should be further understood that the term "U-shaped latch" is not limiting and that any latch mechanism or hook mechanism as defined above may be used.
如上文所讨论，由底部单元形成并且围绕顶部单元的托架空间在装置内部和外部的多个位置采用具有流体传感器的排水路径，以便使得能够分区泄漏探测。具体地，通过将具有光学泄漏传感器的排水路径构建到装置的外部主体中，系统将潜在地从外部部件(例如吸附剂小罐)泄漏的流体捕获和引导至光学泄漏传感器。例如，在一个实施方案中，歧管2130安装在其上并且壳体2125紧贴其停靠和形成空腔的顶部单元的表面2132包括形成倾斜边缘的倾斜表面2190，其用于捕获从歧管2130和歧管2130周围的区域排放或泄漏的水分，并且将水分通过重力引导至定位在中心的湿度传感器2180。优选地，倾斜表面2190足够地倾斜成使落在倾斜边缘上的水分向下朝向定位成接收水分的一个或多个湿度传感器2180运动。在一个实施方案中，一个湿度传感器2180相对于歧管2130的位置在中心定位并且距离每个倾斜表面2190的端部是等距的。As discussed above, the bay space formed by the bottom unit and surrounding the top unit employs drain paths with fluid sensors at various locations inside and outside the device in order to enable zoned leak detection. Specifically, by building a drain path with an optical leak sensor into the external body of the device, the system captures and directs fluid potentially leaking from an external component (eg, a sorbent canister) to the optical leak sensor. For example, in one embodiment, the surface 2132 of the top unit on which the manifold 2130 is mounted and the housing 2125 rests against and forms the cavity includes a sloped surface 2190 that forms a sloped edge for capturing and the area around the manifold 2130 drain or leak moisture, and direct the moisture to the centrally located humidity sensor 2180 by gravity. Preferably, the sloped surface 2190 is sloped sufficiently so that moisture falling on the sloped edge moves downwardly towards the one or more humidity sensors 2180 positioned to receive the moisture. In one embodiment, one humidity sensor 2180 is centrally located relative to the position of the manifold 2130 and equidistant from the end of each sloped surface 2190 .
在一个实施方案中，至少三个不同的光学泄漏探测器集成在底部单元的外部外壳内。参照图22，底部单元2202的顶部表面略微倾斜，中心2280相对于侧部228l和2282被提升。在一个实施方案中，表面从中央区域2280至侧部228l和2282向下倾斜l至10度优选地3度的角度。通道2287环绕底部单元的顶部表面，围绕外周延伸，延伸通过顶部表面的中心，和/或延伸通过顶部表面的任何其他部分。借助于底部单元2202的倾斜顶部表面，通道2287还从中心2280倾斜至侧部2281、2282。在另一个实施方案中，顶部表面还略微地从背部侧229l向下倾斜至前部表面2290。倾斜通道2287使流体被向前地引导远离系统的中心和/或背部并且至泄漏探测器2288被定位和与通道2287流体连通的侧部。In one embodiment, at least three different optical leak detectors are integrated within the outer housing of the bottom unit. Referring to FIG. 22 , the top surface of the bottom unit 2202 is slightly sloped, and the center 2280 is elevated relative to the sides 2281 and 2282 . In one embodiment, the surfaces slope downward from the central region 2280 to the sides 2281 and 2282 at an angle of 1 to 10 degrees, preferably 3 degrees. Channel 2287 encircles the top surface of the bottom unit, extends around the perimeter, extends through the center of the top surface, and/or extends through any other portion of the top surface. The channel 2287 also slopes from the center 2280 to the sides 2281 , 2282 by virtue of the sloped top surface of the bottom unit 2202 . In another embodiment, the top surface also slopes slightly downward from the back side 2291 to the front surface 2290 . Angled channel 2287 causes fluid to be directed forwardly away from the center and/or back of the system and to the side where leak detector 2288 is located and in fluid communication with channel 2287 .
第一光学泄漏探测器2288定位在底部单元2202的顶部表面的前右拐角上。第二光学泄漏探测器2288定位在底部单元2202的顶部表面的前左拐角上。每个泄漏探测器定位在井或空腔内并且包括光学传感器，其位于井的侧部。光学传感器探测已经排出和/或运输至井的流体并且将探测到的信号传输至顶部单元中的控制器。探测到的信号由处理器处理来确定泄漏是否已经发生。探测到的信号然后被存储，并且如果需要的话，处理器使警报或警告显示在GUI上。井或空腔优选地包括被倒圆的基部以允许用户很容易地把井擦拭干燥。图23示出了底部单元2302的顶部表面的更详细的视图，具有通道2387和定位在井2397内的泄漏探测器2388。A first optical leak detector 2288 is positioned on the front right corner of the top surface of the bottom unit 2202 . A second optical leak detector 2288 is positioned on the front left corner of the top surface of the bottom unit 2202 . Each leak detector is positioned within the well or cavity and includes an optical sensor located on the side of the well. An optical sensor detects fluid that has been drained and/or transported to the well and transmits the detected signal to a controller in the head unit. The detected signal is processed by a processor to determine whether a leak has occurred. The detected signal is then stored, and the processor causes an alarm or warning to be displayed on the GUI, if desired. The well or cavity preferably includes a rounded base to allow the user to easily wipe the well dry. FIG. 23 shows a more detailed view of the top surface of bottom unit 2302 , with channel 2387 and leak detector 2388 positioned within well 2397 .
参照图24，至少一个附加的泄漏探测器定位在底部单元2402内且更特别地在储液器2403内部，秤2404集成在其内。通道2405集成到储液器结构例如内部外壳或金属袋保持器中，并且优选地是从一侧倾斜至另一侧或者从中心倾斜至任一侧。在一个实施方案中，倾斜的角度在l至10度的范围内并且更特别的是3度。容纳泄漏探测器的井2410集成到储液器外壳中并且在储液器外壳的一侧或两侧与通道2405流体连通。如果泄漏在一次性袋中发生，则流体将通过通道2405排至金属盘或储液器外壳的拐角，并且被引导到至少一个具有泄漏传感器2410的井中。Referring to Figure 24, at least one additional leak detector is positioned within the bottom unit 2402 and more particularly within the reservoir 2403, into which the scale 2404 is integrated. The channel 2405 is integrated into the reservoir structure such as the inner housing or metal bag holder, and preferably slopes from side to side or from center to either side. In one embodiment, the angle of inclination is in the range of 1 to 10 degrees and more particularly 3 degrees. A well 2410 housing a leak detector is integrated into the reservoir housing and is in fluid communication with channel 2405 on one or both sides of the reservoir housing. If a leak occurs in the disposable bag, fluid will drain through channel 2405 to the metal pan or corner of the reservoir housing and directed into at least one well with leak sensor 2410.
排水路径用于两个功能：a)确保流体不进入仪器，以及b)确保泄漏被迅速地限制并且被引导至可以触发警告或警报的传感器。此外，装置优选地还包括引导至具有在装置的内部上的光学传感器的井的流体排水通道。因此例如，如果在内部储液器中有泄漏，则流体被引导远离关键部件以及泄漏的光学传感器警报。基于激活的传感器，GUI可以把警报呈现给用户并且可以特别地识别流体泄漏的位置。通过提供多个独立的泄漏探测的区域(多个流体传感器和排水路径)，仪器可以引导用户迅速地发现泄漏。具有多个通道和传感器允许系统部分地自动地识别泄漏的源并且向用户提供图形辅助来纠正问题。The drain path serves two functions: a) ensuring that fluid does not enter the instrument, and b) ensuring that leaks are quickly contained and directed to sensors that can trigger a warning or alarm. Furthermore, the device preferably also includes a fluid drainage channel leading to a well with an optical sensor on the interior of the device. So for example, if there is a leak in the internal reservoir, the fluid is directed away from critical components and the optical sensor of the leak alerts. Based on the activated sensors, the GUI can present an alert to the user and can specifically identify the location of the fluid leak. By providing multiple independent areas of leak detection (multiple fluid sensors and drain paths), the instrument can guide the user to find leaks quickly. Having multiple channels and sensors allows the system to partially automatically identify the source of the leak and provide graphical assistance to the user to correct the problem.
下面参照图25，当吸附剂盒2580填充有废物材料时，其膨胀，并且如果未被适当地锚固到基部，则可能翻倒。在一个实施方案中，吸附剂盒2580由多个连接器2540锚固到基部2520并且暂时地物理地附接于此。基部2520是具有连接器2510的平面结构，连接器2510配置成可拆卸地附接到在透析系统基部上的匹配的连接器。在一个实施方案中，基部单元2520包括具有在基部单元上的互补匹配的连接器的两个匹配的连接器2510。连接器2540包括至少两个、优选地三个、或可选地多于三个L形构件。在三连接器配置2540中，连接器围绕着略微比吸附剂盒2580基部的外周更大的外周均匀地分布。当吸附剂盒2580放置在连接器内时，其紧密地装配在其中并且借助盒2580的重量而保持就位。平面表面2520还包括第二组的连接器2550，其包括至少两个、优选地三个、或可选地多于三个L形构件。在三连接器配置2550中，连接器围绕着略微比浓缩液罐基部的外周更大的外周均匀地分布。当浓缩液罐放置在连接器2550内时，其紧密地装配在其中并且借助罐2550的重量而保持就位。Referring now to Figure 25, when the sorbent cartridge 2580 is filled with waste material it expands and may tip over if not properly anchored to the base. In one embodiment, the sorbent cartridge 2580 is anchored to the base 2520 by a plurality of connectors 2540 and is temporarily physically attached thereto. The base 2520 is a planar structure having a connector 2510 configured to be detachably attached to a mating connector on the base of the dialysis system. In one embodiment, the base unit 2520 includes two mating connectors 2510 with complementary mating connectors on the base unit. Connector 2540 includes at least two, preferably three, or optionally more than three L-shaped members. In the three connector configuration 2540, the connectors are evenly distributed around a perimeter slightly larger than the perimeter of the base of the sorbent cartridge 2580. When the sorbent cartridge 2580 is placed within the connector, it fits snugly therein and is held in place by the weight of the cartridge 2580 . Planar surface 2520 also includes a second set of connectors 2550 comprising at least two, preferably three, or optionally more than three L-shaped members. In the three connector configuration 2550, the connectors are evenly distributed around a perimeter slightly larger than the perimeter of the base of the concentrate tank. When the concentrate canister is placed within the connector 2550, it fits snugly therein and is held in place by the weight of the canister 2550.
示例性血液和透析液流体路径Exemplary Blood and Dialysate Fluid Paths
所公开的实施方案可以用于向患者提供透析治疗。图26是本发明的多通的基于吸附剂的透析系统的一个实施方案的功能框图。在一个实施方案中，透析系统2600采用包括高通量膜以将毒素通过扩散并且通过对流从血液中除去的透析器盒2602。通过允许透析液沿一个方向在膜的一侧上流动并且同时允许血液沿相反的方向在膜的另一侧上流动而建立在整个半渗透膜上的浓度梯度，从而实现通过扩散除去毒素。为了增强使用血液透析滤过来除去毒素，置换液被连续地加入到血液中，在透析器盒之前(前稀释)或在透析器盒之后(后稀释)。量等于被加入的置换液的量的流体在整个透析器盒膜上被“超滤”，随其携带被加入的溶质。The disclosed embodiments can be used to provide dialysis treatment to patients. Figure 26 is a functional block diagram of one embodiment of the multi-port sorbent-based dialysis system of the present invention. In one embodiment, the dialysis system 2600 employs a dialyzer cassette 2602 that includes high flux membranes to remove toxins from the blood by diffusion and by convection. Removal of toxins by diffusion is achieved by allowing dialysate to flow in one direction on one side of the membrane while allowing blood to flow in the opposite direction on the other side of the membrane creating a concentration gradient across the semi-permeable membrane. To enhance the use of hemodiafiltration to remove toxins, replacement fluid is continuously added to the blood either before the dialyzer cassette (pre-dilution) or after the dialyzer cassette (post-dilution). An amount of fluid equal to the amount of replacement fluid added is "ultrafiltered" across the membrane of the dialyzer cartridge, carrying with it the added solute.
同时参照图26和27，在一个实施方案中，含有毒素的血液被血液泵260l、270l从患者的血管泵送，并且被传递以流过透析器盒2602、2702。可选地，血液回路中的入口和出口压力传感器2603、2604、2703、2704在血液经由血液入口管2605、2705进入透析器盒2602、2702之前并且在经由血液出口管2606、2706离开透析器盒2602、2702之后测量血液的压力。来自传感器2603、2604、2628、2703、2704、2728的压力读数用作血液流动的监视和控制参数。流量计262l、272l可以被置于血液入口管2605、2705的定位在血液泵260l、270l的紧邻上游的部分中或以其他方式与该部分压力连通。流量计262l、272l定位成监视和保持不纯净血液供应管线中的血液的预定流量。置换液2690可以被连续地加入血液中，在透析器盒之前(前稀释)或在透析器盒之后(后稀释)。Referring to FIGS. 26 and 27 concurrently, in one embodiment, toxin-containing blood is pumped by blood pumps 2601 , 2701 from the patient's blood vessels and passed to flow through the dialyzer cassette 2602 , 2702 . Optionally, inlet and outlet pressure sensors 2603, 2604, 2703, 2704 in the blood circuit before blood enters the dialyzer cassette 2602, 2702 via the blood inlet tube 2605, 2705 and before the blood exits the dialyzer cassette via the blood outlet tube 2606, 2706 After 2602, 2702 the pressure of the blood is measured. Pressure readings from sensors 2603, 2604, 2628, 2703, 2704, 2728 are used as monitoring and control parameters for blood flow. The flow meter 2621, 2721 may be placed in or otherwise in pressure communication with a portion of the blood inlet tube 2605, 2705 positioned immediately upstream of the blood pump 2601, 2701. Flow meters 2621, 2721 are positioned to monitor and maintain a predetermined flow of blood in the impure blood supply line. The replacement fluid 2690 can be added to the blood continuously, either before the dialyzer cassette (pre-dilution) or after the dialyzer cassette (post-dilution).
在一个实施方案中，参照图26和27，透析器盒2602、2702包括将透析器2602、2702分成血液室2609、2709和透析液室2611、2711的半渗透膜2608、2708。随着血液经过血液室2609、2709，尿毒症毒素由于对流力而被滤过整个半渗透膜2608、2708。另外的血液毒素通过扩散而在整个半渗透膜2608、2708上被传递，主要是由分别地流过血液室和透析液室2609、2709和2611、2711的流体的浓度的差异诱导。所使用的透析器盒可以是具有任何适于血液透析、血液透析滤过、血液滤过或血液浓缩的类型，如本领域中已知的。在一个实施方案中，透析器2602、2702容纳高通量膜。合适的透析器盒的示例包括但不限于可从肯塔基州的列克星敦的FreseniusMedicalCare获得的F80、可从伊利诺伊州的迪尔菲尔德的Baxter获得的BaxterCTll0，CTl90，或者可从明尼苏达州的明尼阿波利斯的Minntech获得的MinntechHemocor2000。In one embodiment, referring to FIGS. 26 and 27 , a dialyzer cassette 2602 , 2702 includes a semipermeable membrane 2608 , 2708 that divides the dialyzer 2602 , 2702 into a blood compartment 2609 , 2709 and a dialysate compartment 2611 , 2711 . As the blood passes through the blood chambers 2609, 2709, uremic toxins are filtered through the semi-permeable membranes 2608, 2708 due to convective forces. Additional blood toxins are delivered across the semi-permeable membranes 2608, 2708 by diffusion, mainly induced by differences in the concentrations of the fluids flowing through the blood and dialysate compartments 2609, 2709 and 2611, 2711, respectively. The dialyzer cassette used may be of any type suitable for hemodialysis, hemodiafiltration, hemofiltration or hemoconcentration, as known in the art. In one embodiment, the dialyzers 2602, 2702 house high flux membranes. Examples of suitable dialyzer cassettes include, but are not limited to, available from Fresenius Medical Care of Lexington, Kentucky. F80, Baxter CT110, CT190, available from Baxter of Deerfield, Illinois or Minntech Hemocor available from Minntech in Minneapolis, Minnesota 2000.
在本发明的一个实施方案中，透析液泵2607、2707把已消耗的透析液从透析器盒2602、2702抽取并且强迫透析液进入透析液再生系统2610、2710中并且在多通环路中返回2613、2713到透析器盒2602、2702中，从而产生“再生的”或新鲜的透析液。可选地，流量计2622、2722被置于在从透析液泵2607、2707的上游的已消耗透析液供应管2612、2712中，流量计2622、2722监视并且保持透析液的预定流量。血液泄漏传感器2623、2723也被置于已消耗透析液供应管2612、2712中。In one embodiment of the invention, the dialysate pumps 2607, 2707 draw spent dialysate from the dialyzer cassette 2602, 2702 and force the dialysate into the dialysate regeneration system 2610, 2710 and back in a multi-way loop 2613, 2713 into the dialyzer cassette 2602, 2702, thereby producing "regenerated" or fresh dialysate. Optionally, a flow meter 2622, 2722 is placed in the spent dialysate supply line 2612, 2712 upstream from the dialysate pump 2607, 2707, the flow meter 2622, 2722 monitors and maintains a predetermined flow of dialysate. A blood leak sensor 2623 , 2723 is also placed in the spent dialysate supply tube 2612 , 2712 .
本发明的多通透析液再生系统2610、2710包括多个包含用于再生已消耗透析液的吸附剂的盒和/或过滤器。通过使用吸附剂盒来再生透析液，本发明的透析系统2600、2700仅需要常规单通血液透析装置的透析液的量的一小部分。The multi-pass dialysate regeneration system 2610, 2710 of the present invention includes a plurality of cartridges and/or filters containing sorbents for regeneration of spent dialysate. By using a sorbent cartridge to regenerate the dialysate, the dialysis system 2600, 2700 of the present invention requires only a fraction of the amount of dialysate of a conventional single-pass hemodialysis device.
在一个实施方案中，透析液再生系统2610、2710中的每个吸附剂盒是包含不同吸附剂的微型化盒。例如，透析液再生系统2610、2710可以采用五个吸附剂盒，其中每个盒单独包含活性炭、尿素酶、磷酸锆、水合氧化锆和活性炭。在另一个实施方案中，每个盒可以包括上文描述的多层吸附剂，并且在透析液再生系统中可以具有彼此串联或并联连接的多个这种分离的分层盒。本领域技术人员要理解的是，活性炭、尿素酶、磷酸锆、水合氧化锆和活性炭不是仅有的可以在本发明中用作吸附剂的化学物。实际上，在不偏离本发明范围的情况下，可以采用任何数量的额外的或可替代的吸附剂(包括基于聚合物的吸附剂)。In one embodiment, each sorbent cartridge in the dialysate regeneration system 2610, 2710 is a miniaturized cartridge comprising a different sorbent. For example, the dialysate regeneration system 2610, 2710 may employ five sorbent cartridges, where each cartridge individually contains activated carbon, urease, zirconium phosphate, hydrous zirconia, and activated carbon. In another embodiment, each cartridge may comprise a multilayer sorbent as described above, and there may be a plurality of such separate layered cartridges connected in series or parallel to each other in a dialysate regeneration system. Those skilled in the art will understand that activated carbon, urease, zirconium phosphate, hydrous zirconia and activated carbon are not the only chemicals that can be used as adsorbents in the present invention. In fact, any number of additional or alternative sorbents (including polymer-based sorbents) may be employed without departing from the scope of the present invention.
本发明的基于吸附剂的多通透析系统提供相对于常规单通系统的多个优点。这些包括：The sorbent-based multi-pass dialysis system of the present invention offers several advantages over conventional single-pass systems. These include:
●不需要连续的水源、分离的水净化机器或地板排水，因为本发明的系统连续地再生一定体积的透析液。这允许加强的便携性。• No need for a continuous water source, separate water purification machine or floor drain as the system of the invention continuously regenerates a volume of dialysate. This allows enhanced portability.
●本发明的系统需要低电流电源，例如15安培，因为系统通过渗滤程序循环利用同一个小体积的透析液。因此，不需要用于单通透析系统中的大体积的透析液的额外的透析液泵、浓缩液泵和大加热器。• The system of the present invention requires a low current power source, eg 15 amps, because the system recycles the same small volume of dialysate through the diafiltration procedure. Therefore, no additional dialysate pumps, concentrate pumps and large heaters are required for the large volumes of dialysate in a single-pass dialysis system.
●本发明的系统可以使用低体积的自来水，在6升的范围内，透析液可以在整个治疗期间由自来水制备。• The system of the invention can use low volumes of tap water, in the range of 6 liters, from which dialysate can be prepared throughout the treatment period.
●吸附剂系统使用作为水净化器并且作为用于将使用过的透析液再生为新鲜的透析液的手段而起作用的吸附剂盒。• The sorbent system uses a sorbent cartridge that functions as a water purifier and as a means for regenerating used dialysate into fresh dialysate.
虽然目前的实施方案具有用于将血液和透析液泵送通过透析器的分离的泵260l、270l、2607、2707，但是在替代实施方案中，可以采用将血液和透析液二者推进通过血液透析滤过系统2600、2700的单一双通道搏动泵。此外，还可以使用离心泵、齿轮泵或膜片泵。While the current embodiment has separate pumps 2601 , 2701 , 2607 , 2707 for pumping blood and dialysate through the dialyzer, in alternative embodiments, a pump that pushes both blood and dialysate through the hemodialysis pump may be used. Single dual channel pulsatile pump for filtration systems 2600, 2700. In addition, centrifugal pumps, gear pumps or diaphragm pumps can also be used.
在一个实施方案中，过量的流体废物通过使用体积废物微型泵2614、2714而从已消耗透析液管2612、2712中的已消耗的透析液除去并且沉积到废物收集储液器2615、2715中，废物收集储液器可以通过出口例如水龙头而被周期性地排空。包括微处理器的电子控制单元2616监视并且控制系统2600的所有部件的功能。In one embodiment, excess fluid waste is removed from spent dialysate in spent dialysate lines 2612, 2712 and deposited into waste collection reservoirs 2615, 2715 by using volumetric waste minipumps 2614, 2714, The waste collection reservoir may be periodically emptied through an outlet such as a tap. An electronic control unit 2616 including a microprocessor monitors and controls the functions of all components of the system 2600 .
在一个实施方案中，离开透析器盒2602、2702的已渗滤的血液与被从置换液容器2617、2717通过体积微型泵2618、2718泵送到血液出口管2606、2706中的已调节的体积的无菌置换液混合。置换液通常可作为包含在柔性袋中的无菌/非发热流体。该流体还可以通过非无菌透析液经过合适滤筒的过滤而被在线地生产，使其是无菌且非发热的。In one embodiment, the diafiltered blood leaving the dialyzer cassette 2602, 2702 is pumped from the replacement fluid container 2617, 2717 by the volumetric micropump 2618, 2718 into the blood outlet tube 2606, 2706 with an adjusted volume Mix the sterile replacement solution. Replacement fluid is usually available as a sterile/non-pyrogenic fluid contained in a flexible bag. The fluid can also be produced in-line by filtration of non-sterile dialysate through a suitable cartridge, making it sterile and non-pyrogenic.
图28是示出了本发明超滤治疗系统2800的一个实施方案的功能框图。如图28所示，来自患者的血液被泵例如蠕动血液泵2802抽到血液入口管路280l中，该泵迫使血液经由血液入口端口2803进入血液滤器盒2804。入口和出口压力换能器2805、2806恰好在线地连接在血液泵2802之前和之后。血液滤器2804包括半渗透膜，其允许过量的流体通过对流而从穿过其的血液超滤。已超滤的血液被进一步从血液滤器2804通过血液出口端口2807泵送出来，进入血液出口管路2808，以输注返回到患者中。调节器例如夹持器2809、2810用于管路280l和2808来调节经过其的流体流动。Figure 28 is a functional block diagram illustrating one embodiment of an ultrafiltration therapy system 2800 of the present invention. As shown in FIG. 28 , blood from the patient is drawn into blood inlet line 2801 by a pump, such as peristaltic blood pump 2802 , which pumps the blood into hemofilter cassette 2804 via blood inlet port 2803 . Inlet and outlet pressure transducers 2805, 2806 are connected just before and after the blood pump 2802 in-line. Hemofilter 2804 includes a semi-permeable membrane that allows excess fluid to be ultrafiltered from blood passing therethrough by convection. Ultrafiltered blood is further pumped out of hemofilter 2804 through blood outlet port 2807 into blood outlet line 2808 for infusion back into the patient. Regulators such as clamps 2809, 2810 are used in lines 2801 and 2808 to regulate fluid flow therethrough.
压力换能器2811连接在血液出口端口2807附近，随后是在压力换能器2811下游的空气泡探测器2812。超滤液泵例如蠕动泵2813将超滤液废物经由UF(超滤液)出口端口2814从血液滤器2804抽取并进入UF出口管路2815。压力换能器2816和血液泄漏探测器2817被置换到UF出口管路2815中。超滤液废物最终被泵送到废物收集储液器2818例如烧瓶或软袋子中，废物收集储液器附接到走动的患者的腿部并且配备有排水端口以允许间歇的排空。所产生的超滤液废物的量可以通过使用任何测量技术而被监视，包括秤2819或流量计。微控制器2820监视并且管理血液泵和UF泵、压力传感器以及空气和血液泄漏探测器的功能。标准的鲁尔连接部例如鲁尔滑动器和鲁尔锁定器用于将管路连接到泵、血液滤器以及连接到患者。A pressure transducer 2811 is connected near the blood outlet port 2807, followed by an air bubble detector 2812 downstream of the pressure transducer 2811. An ultrafiltrate pump such as a peristaltic pump 2813 draws ultrafiltrate waste from the hemofilter 2804 via the UF (ultrafiltrate) outlet port 2814 and into the UF outlet line 2815 . Pressure transducer 2816 and blood leak detector 2817 are displaced into UF outlet line 2815. The ultrafiltrate waste is eventually pumped into a waste collection reservoir 2818, such as a flask or soft bag, which is attached to the ambulatory patient's leg and is equipped with a drain port to allow intermittent emptying. The amount of ultrafiltrate waste produced can be monitored using any measurement technique, including scales 2819 or flow meters. Microcontroller 2820 monitors and manages the functions of blood and UF pumps, pressure sensors, and air and blood leak detectors. Standard luer connections such as luer sliders and luer locks are used to connect tubing to pumps, hemofilters, and to patients.
另一个能够在透析系统的实施方案中实施或使用的血液和透析液回路在图29中示出。图29描绘了用于进行血液透析和血液滤过的体外血液处理系统2900的流体回路。在本发明的一个实施方案中，系统2900被实施为可以由患者用于在家进行透析的便携式透析系统。血液透析系统包括两个回路，即血液回路290l和透析液回路2902。在透析期间的血液处理涉及通过具有半渗透膜—血液透析器或透析器2903的交换器的体外循环。患者的血液在血液回路290l中在膜(透析器)2903的一侧上循环，而透析液(包括以由医师规定的浓度的血液的主要电解质)在透析液回路2902中在另一侧上循环。透析液的循环因此提供血液中的电解质浓度的调节和调整。Another blood and dialysate circuit that can be implemented or used in an embodiment of a dialysis system is shown in FIG. 29 . Figure 29 depicts the fluid circuit of an extracorporeal blood treatment system 2900 for performing hemodialysis and hemofiltration. In one embodiment of the invention, system 2900 is implemented as a portable dialysis system that can be used by a patient to perform dialysis at home. The hemodialysis system includes two circuits, a blood circuit 2901 and a dialysate circuit 2902 . Blood treatment during dialysis involves extracorporeal circulation through an exchanger with a semipermeable membrane—the hemodialyzer or dialyzer 2903 . The patient's blood circulates on one side of the membrane (dialyzer) 2903 in the blood circuit 2901 , while the dialysate (comprising blood's main electrolytes in concentrations prescribed by the physician) circulates on the other side in the dialysate circuit 2902 . The circulation of the dialysate thus provides regulation and adjustment of the electrolyte concentration in the blood.
从患者的管线2904将不纯净的血液运输到血液回路290l中的透析器2903，设置有闭塞探测器2905，其大体上与视觉或听觉警报联系以将任何障碍物的信号通知给血液流动。为了防止血液的凝结，用于将抗凝剂例如肝素注射到血液中的递送装置2906例如泵、注射器或任何其他注射装置也被提供。蠕动泵2907还被提供用于确保血液沿正常的(期望的)方向流动。The dialyzer 2903, which transports impure blood from the patient's line 2904 into the blood circuit 2901, is provided with an occlusion detector 2905, generally associated with a visual or audible alarm to signal any obstruction to the blood flow. In order to prevent coagulation of the blood, a delivery device 2906 such as a pump, syringe or any other injection device for injecting an anticoagulant such as heparin into the blood is also provided. A peristaltic pump 2907 is also provided to ensure blood flow in the normal (desired) direction.
压力传感器2908设置在不纯净血液进入透析器2903的入口处。其他的压力传感器2909、2910、2911和2912设置在血液透析系统中的各个位置来追踪并将在相应回路内的特定点处的流体压力保持在期望的水平。The pressure sensor 2908 is placed at the inlet of the impure blood into the dialyzer 2903 . Other pressure sensors 2909, 2910, 2911 and 2912 are placed at various locations in the hemodialysis system to track and maintain the fluid pressure at a desired level at a particular point within the respective circuit.
血液泄漏传感器2913设置在来自透析器2903的使用过的透析液流体进入透析液回路2902的点处，以感测并警报血细胞进入透析液回路的任何泄漏。一对旁通阀2914也设置在透析液回路的开始点和结束点，使得在启动的条件下，或者在其他由操作者视为必要的时间，透析器可以被从透析液流体流动绕过，而透析液流体流动可以仍被保持，即用于冲洗或预充操作。另一个阀2915恰好设置在预充/排水端口2916之前。端口2916用于初始采用透析液溶液填充回路，并且以在透析之后以及在某些情况下在透析期间除去使用过的透析液流体。在透析期间，阀2915可以用于采用具有合适浓度的补充流体代替使用过的透析液的具有例如钠的高浓度的部分，使得透析液的总体组分浓度维持在期望的水平。A blood leak sensor 2913 is provided at the point where used dialysate fluid from the dialyzer 2903 enters the dialysate circuit 2902 to sense and alert any leak of blood cells into the dialysate circuit. A pair of bypass valves 2914 are also provided at the start and end points of the dialysate circuit so that the dialyzer may be bypassed from dialysate fluid flow under start-up conditions, or at other times deemed necessary by the operator, However, the dialysate fluid flow can still be maintained, ie for flushing or priming operations. Another valve 2915 is placed just before the priming/draining port 2916. Port 2916 is used to initially fill the circuit with dialysate solution, and to remove used dialysate fluid after dialysis and, in some cases, during dialysis. During dialysis, valve 2915 may be used to replace the portion of the used dialysate having a high concentration, eg sodium, with a make-up fluid having an appropriate concentration so that the overall component concentrations of the dialysate are maintained at desired levels.
透析液回路设置有两个蠕动泵2917和2918。泵2917用于将透析液流体泵送至排水或废物容器，以及用于将已再生的透析液泵送到透析器2903中。泵2918用于将已消耗的透析液从透析器2903泵送出来，保持通过吸附剂2919的流体压力，并且将透析流体从端口2916泵送来填充系统或保持透析液中的组分浓度。The dialysate circuit is provided with two peristaltic pumps 2917 and 2918. Pump 2917 is used to pump dialysate fluid to a drain or waste container, and to pump regenerated dialysate into dialyzer 2903 . Pump 2918 is used to pump spent dialysate out of dialyzer 2903, maintain fluid pressure through sorbent 2919, and pump dialysate fluid from port 2916 to fill the system or maintain component concentrations in the dialysate.
吸附剂盒2919设置在透析液回路2902中。吸附剂盒2919包含多层材料，每个具有除去杂质例如尿素和肌酸酐的作用。这些分层的材料的组合允许适于饮用的水被加载到系统中用作透析液流体。其还允许闭环透析。也就是说，吸附剂盒2919使得能够由来自透析器2903的已消耗的透析液再生为新鲜的透析液。具有合适容量例如0.5、l、5、8或10升的内衬容器或储液器2920被提供用于新鲜的透析液流体。A sorbent cartridge 2919 is disposed in the dialysate circuit 2902 . The sorbent cartridge 2919 contains multiple layers of materials, each having the function of removing impurities such as urea and creatinine. The combination of these layered materials allows potable water to be loaded into the system for use as dialysate fluid. It also allows closed loop dialysis. That is, the sorbent cartridge 2919 enables regeneration of fresh dialysate from spent dialysate from the dialyzer 2903 . A lined container or reservoir 2920 with a suitable volume, eg, 0.5, 1, 5, 8 or 10 liters, is provided for fresh dialysate fluid.
取决于患者要求并且基于医师的处方，可以将所期望的量的输注溶液292l加入到透析流体中。输注液292l是含有矿物质和/或葡萄糖的溶液，其有助于在透析液流体中的矿物质例如钾和钙在被吸附剂非期望移除之后对其补充到所需水平。蠕动泵2922被提供以将所期望的量的输注溶液292l泵送至容器2920。可替代地，输注溶液292l可以泵送到来自储液器2920的流出管线中。照相机2923可选地被提供以监视输注溶液的改变的液面作为输注液流动故障的安全检查警报和/或作为用于扫描与要被用于透析程序中的添加剂相关联的条形码的条形码传感器起作用。可选地，可以提供氨传感器2928。Depending on patient requirements and based on the physician's prescription, a desired amount of infusion solution 2921 may be added to the dialysis fluid. Infusion solution 2921 is a solution containing minerals and/or glucose that helps to replenish minerals such as potassium and calcium in the dialysate fluid to desired levels after they have been undesirably removed by the sorbent. A peristaltic pump 2922 is provided to pump the desired volume of infusion solution 2921 to the container 2920. Alternatively, infusion solution 2921 may be pumped into the outflow line from reservoir 2920 . A camera 2923 is optionally provided to monitor changing levels of the infusion solution as a safety check alert for infusion fluid flow failures and/or as a barcode for scanning barcodes associated with additives to be used in the dialysis procedure The sensor works. Optionally, an ammonia sensor 2928 may be provided.
加热器2924被提供以将容器2920中的透析液流体的温度保持在所需水平。透析液流体的温度可以由恰好定位在流体进入透析器2903的入口之前的温度传感器2925感测。容器2920还配备有用于保持追踪容器2920中的流体的重量且因此体积的秤2926以及确定和监视透析液流体的电导率的电导传感器2927。电导传感器2927提供透析液中的钠水平的指示。A heater 2924 is provided to maintain the temperature of the dialysate fluid in container 2920 at a desired level. The temperature of the dialysate fluid may be sensed by a temperature sensor 2925 positioned just before the fluid enters the inlet of the dialyzer 2903 . The container 2920 is also equipped with a scale 2926 for keeping track of the weight and thus volume of the fluid in the container 2920 and a conductivity sensor 2927 for determining and monitoring the conductivity of the dialysate fluid. Conductivity sensor 2927 provides an indication of the sodium level in the dialysate.
医用端口2929设置在来自患者的血液进入系统进行透析之前。另一个医用端口2930设置在来自透析器2903的清洁血液返回至患者之前。空气(或气泡)传感器293l以及弹簧夹2932在回路中采用，以探测并且防止任何空气、气体或气泡返回至患者。A medical port 2929 is provided before blood from the patient enters the system for dialysis. Another medical port 2930 is placed before the clean blood from the dialyzer 2903 is returned to the patient. An air (or air bubble) sensor 2931 and spring clip 2932 are employed in the circuit to detect and prevent any air, gas or air bubbles from returning to the patient.
预充套件2933附接到透析系统2900，该预充套件通过在血液回路290l用于透析之前采用无菌盐水对其填充来帮助准备系统。预充套件可以包括具有预附接的IV袋尖刺或IV针或二者的组合的管路的短节段。Attached to the dialysis system 2900 is a priming set 2933 that helps prepare the system by filling the blood circuit 2901 with sterile saline before it is used for dialysis. The priming set may include a short section of tubing with a pre-attached IV bag spike or IV needle or a combination of both.
应当理解的是，虽然上文提到的实施方案中的某些公开了结合并使用接收抗凝剂的注射或施用的端口，由此产生空气—血液接口连接，但这样的端口可以被消除，如果装置可以采用血液在入口和出口的端口处凝结的最小风险操作的话。如下文进一步所讨论，歧管设计特别是关于歧管端口的内部设计尽量减小血液凝结的风险，从而产生消除用于接收抗凝剂的注射或施用的空气—血液接口连接的选项。It should be appreciated that while certain of the above-mentioned embodiments disclose the incorporation and use of ports to receive injection or administration of anticoagulant, thereby creating an air-to-blood interface connection, such ports may be eliminated, If the device can be operated with minimal risk of blood clotting at the inlet and outlet ports. As discussed further below, the manifold design, particularly with respect to the internal design of the manifold ports, minimizes the risk of blood clotting, creating the option of eliminating air-to-blood interface connections for receiving injections or administrations of anticoagulants.
本领域技术人员将从上文讨论推测出的是，用于血液透析和/或血液滤过系统的示例性流体回路很复杂。如果以常规的方式实施，则系统将作为管路的网操作并且将对于家庭透析用户配置和使用来说过于复杂。因此，为了使系统是对于患者在家使用来说简单易用，本发明的实施方案实施紧凑歧管形式的流体回路，其中流体回路的大多数部件集成到单件模制塑料或配置成连接在一起以形成单一操作性歧管结构的多件模制塑料中。Those skilled in the art will infer from the above discussion that exemplary fluid circuits for hemodialysis and/or hemofiltration systems are complex. If implemented in a conventional manner, the system would operate as a network of tubing and would be too complex for home dialysis users to configure and use. Therefore, in order for the system to be simple and easy for the patient to use at home, embodiments of the present invention implement a fluid circuit in the form of a compact manifold where most components of the fluid circuit are integrated into a single piece of molded plastic or configured to be connected together in multiple pieces of molded plastic to form a single operative manifold structure.
示例性歧管Exemplary Manifold
应当理解的是，由上文描述的血液和透析液回路表示的多通透析治疗过程可以在被模制到一次性歧管中的多个血液和透析液回路内实施并且由其实施。如图21所示，本文公开的透析系统的实施方案通过使用限定多个血液和透析液回路并且将流体置于与各种传感器、计量器和泵压力、热和/或光学连通的歧管2130来操作。It should be understood that the multipass dialysis treatment process represented by the blood and dialysate circuits described above may be implemented within and by multiple blood and dialysate circuits molded into the disposable manifold. As shown in FIG. 21 , embodiments of the dialysis system disclosed herein utilize a manifold 2130 that defines multiple blood and dialysate circuits and places the fluids in pressure, thermal and/or optical communication with various sensors, gauges and pumps. to operate.
在一个实施方案中，本发明的歧管包括其中模制有血液和透析液流动路径的复合塑料歧管。血液净化系统部件例如传感器和泵被置于与包含在模制歧管内的流体流动压力、热和/或光学连通。图30示出了根据本发明的一个实施方案的紧凑歧管的结构元件。一次性歧管泵送并且引导流体流动，同时测量关键区域中的压力。这些流体包括血液、透析液、输注液和抗凝剂。此外，歧管提供以下特征，即用于探测来自透析器的血液泄漏的、探测动脉管路中的闭塞和探测静脉管路中的空气。In one embodiment, the manifold of the present invention comprises a composite plastic manifold with blood and dialysate flow paths molded therein. Blood purification system components such as sensors and pumps are placed in fluid flow pressure, thermal and/or optical communication with the fluid contained within the molded manifold. Figure 30 shows the structural elements of a compact manifold according to one embodiment of the invention. Disposable manifolds pump and direct fluid flow while measuring pressure in critical areas. These fluids include blood, dialysate, infusion fluid, and anticoagulants. Additionally, the manifold provides features for detecting blood leaks from the dialyzer, detecting occlusions in the arterial line, and detecting air in the venous line.
参照图30，在一个实施方案中，紧凑歧管3000包括多个塑料层，部件被牢固地附接在其中。更特别地，歧管3000包括以下元件：Referring to Figure 30, in one embodiment, a compact manifold 3000 includes multiple layers of plastic into which components are securely attached. More specifically, manifold 3000 includes the following elements:
●背部覆盖物300l●Back cover 300l
●压力换能器膜3002●Pressure transducer membrane 3002
●阀膜3003●Diaphragm 3003
●中部体3004●Middle body 3004
●前部覆盖物3005●Front cover 3005
●泵管节段(在图30中未示出)• Pump tubing segments (not shown in Figure 30)
中部体层3004在一侧上部件模制入的通道。这些通道由前部覆盖物层完成，前部覆盖物层由任何数量的方法包括超声焊接牢固地附接到中部体。这种组合的前部覆盖物—中部体结构在歧管内形成流体路径的主要部分。在中部体3004的相反侧上具有形成用于阀调和压力感测的表面的特征，该特征连通至在歧管的前部覆盖物侧上的流体路径。歧管包括用于阀调和压力感测的弹性体部件。这些弹性体部件通过使用超声焊接而被捕获在背部覆盖物层与中部体层之间，并且完成通过歧管的流体路径。The middle body layer 3004 has channels molded into it on one side. These channels are completed by a front covering layer that is securely attached to the midbody by any number of methods including ultrasonic welding. This combined front cover-midbody structure forms the majority of the fluid path within the manifold. On the opposite side of the mid-body 3004 there are features forming surfaces for valving and pressure sensing that communicate to the fluid paths on the front cover side of the manifold. The manifold includes elastomeric components for valve regulation and pressure sensing. These elastomeric components are captured between the back cover layer and mid body layer using ultrasonic welding and complete the fluid path through the manifold.
参照图30，在一个实施方案中，歧管3000包括五个压力换能器膜3002和三个至四个用于二通阀的膜3003。在一个实施方案中，两个覆盖物300l和3005以及歧管3000的中部体3004由聚碳酸酯材料或ABS(丙烯腈丁二烯苯乙烯)模制。压力换能器膜3002和阀膜3003由普通的材料模制，例如Santoprene或更优选的是Sarlink，其是一种医疗级弹性聚合物。在一个实施方案中，前部和背部覆盖物3005和300l可以由光学透明材料模制，至少对光的某些预选择的波长是透明的，以允许包含在其内的流体的光谱分析。Referring to Figure 30, in one embodiment, a manifold 3000 includes five pressure transducer membranes 3002 and three to four membranes 3003 for two-way valves. In one embodiment, the two covers 3001 and 3005 and the central body 3004 of the manifold 3000 are molded from polycarbonate material or ABS (acrylonitrile butadiene styrene). The pressure transducer membrane 3002 and valve membrane 3003 are molded from common materials such as Santoprene or more preferably Sarlink, which is a medical grade elastic polymer. In one embodiment, the front and back covers 3005 and 3001 may be molded from an optically transparent material, transparent to at least certain preselected wavelengths of light, to allow spectroscopic analysis of the fluid contained therein.
此外，歧管优选地包括四个泵送部件。这些泵送部件是挤压成形的PVC管路的节段，成分和尺寸被确定成具有对于泵使用特别是滚子泵使用来说优化的性能。该管路结合到一体模制至歧管中部体的倒钩配件。四个泵送部件之一用于将血液从患者的动脉中抽出并且将其泵送通过透析器并且泵送返回至患者的静脉。两个泵送部件用于透析液流动，一个用于输注递送到透析液流体回路。分离的注射器泵可用于将抗凝剂泵送到动脉血路径、预透析器中。Furthermore, the manifold preferably includes four pumping components. These pumping components are segments of extruded PVC tubing, composition and size determined to have optimized performance for pump use, particularly roller pump use. The tubing is joined to barb fittings integrally molded to the manifold midbody. One of the four pumping components is used to draw blood from the patient's artery and pump it through the dialyzer and back into the patient's vein. Two pumping components are used for dialysate flow and one for infusion delivery to the dialysate fluid circuit. A separate syringe pump can be used to pump anticoagulant into the arterial blood path, pre-dialyzer.
在一个实施方案中，歧管还结合有管路端口，优选地在10—14个的范围内并且更优选的是12个端口，用于将歧管内的所有流体路径连接到一次性套件中的其他部件，包括透析器、吸附剂盒、袋储液器、输注液容器、患者血液线、抗凝剂、传感器、预充管线和排放管线，如下文进一步讨论。In one embodiment, the manifold also incorporates tubing ports, preferably in the range of 10-14 and more preferably 12 ports, for connecting all fluid paths within the manifold to the ports in the disposable set. Other components, including dialyzers, sorbent cartridges, bag reservoirs, infusion fluid containers, patient blood lines, anticoagulants, sensors, priming lines, and drain lines, are discussed further below.
在一个实施方案中，歧管的形状如大写字母“I”，具有彼此平行的第一节段和第二节段以及连接节段，连接节段a)垂直于第一节段和第二节段并且b)用于连接第一节段和第二节段。在一个实施方案中，连接节段将第一节段的中部连接到第二节段的中部，从而使连接节段与第一节段和第二节段的每个端部之间的距离是等距的。应当理解的是，连接节段可以放置在第一和第二节段的端部处，从而做出大写字母“C”或反向的“C”。歧管还可以相对于透析系统旋转，并且不需要定位为大写字母“I”，例如其可以定位在其侧上或以一定角度定位。如图32所示，在示例性实施方案中，歧管3200具有如下尺寸：Ll和L2在4至7英寸的范围内，并且优选地约5.7英寸，L3和L4在0.5至1.5英寸的范围内，并且优选地约l英寸，L5在2.5至4.5英寸的范围内，并且优选地约3.5英寸，且L6在l至3英寸的范围内，并且优选地约1.8英寸。虽然尺寸已经被提供，但应当理解的是，本文所公开的发明不限于任何具体的尺寸或尺寸的集合。In one embodiment, the manifold is shaped like a capital letter "I" with first and second segments parallel to each other and a connecting segment a) perpendicular to the first and second segments segment and b) for connecting the first segment and the second segment. In one embodiment, the connecting segment connects the middle of the first segment to the middle of the second segment such that the distance between the connecting segment and each end of the first and second segments is isometric. It should be understood that a connecting segment may be placed at the ends of the first and second segments, making a capital "C" or a reverse "C". The manifold can also be rotated relative to the dialysis system and need not be positioned as a capital "I", for example it could be positioned on its side or at an angle. As shown in FIG. 32, in an exemplary embodiment, manifold 3200 has the following dimensions: L1 and L2 are in the range of 4 to 7 inches, and preferably about 5.7 inches, and L3 and L4 are in the range of 0.5 to 1.5 inches , and preferably about 1 inch, L5 is in the range of 2.5 to 4.5 inches, and preferably about 3.5 inches, and L6 is in the range of 1 to 3 inches, and preferably about 1.8 inches. Although dimensions have been provided, it should be understood that the invention disclosed herein is not limited to any particular size or set of sizes.
在一个实施方案中，歧管3000的组装过程包括将背部覆盖物300l匹配至中部体3004，同时通过使膜的第一侧物理地附接或接触中部体并且使膜的第二侧穿过背部覆盖物300l中的洞、空间或空穴3011来将膜3002和3003固定就位。覆盖物300l可以被分成两个部分，即顶部部分和底部部分，其中顶部部分包括中央竖直部分3082的顶部部分和顶部水平片段3080，底部部分包括中央竖直部分3084的底部部分和底部水平片段3085。在本实施方案中，覆盖物300l的顶部和底部部分可以被单独地附接到中部体3004，并且相对于连续的覆盖物300l，可以不包括在中央竖直部分的中部片段区域3083中的材料来节约材料成本。优选地，膜的第二侧具有有层级的结构，其允许第一层级穿过空穴3011，而第二层级保持在背部覆盖物300l和中部体3004之间。这将膜3002、3003固定到背部覆盖物300l中。此外，优选的是，中部体3004包含膜3002、3003的第一侧停靠在其中的凹陷部，从而将它们固定到中部体3004。在可选择的配置中，膜3002和3003可以在多重模制过程中被共模至背部覆盖物300l。In one embodiment, the assembly process of the manifold 3000 includes mating the back cover 3001 to the mid-body 3004 while physically attaching or contacting the mid-body with the first side of the membrane and passing the second side of the membrane through the back Holes, spaces or cavities 3011 in cover 300l to hold membranes 3002 and 3003 in place. The cover 3001 may be divided into two sections, a top section comprising a top section of a central vertical section 3082 and a top horizontal section 3080 and a bottom section comprising a bottom section of a central vertical section 3084 and a bottom horizontal section 3085. In this embodiment, the top and bottom portions of the covering 3001 may be attached separately to the central body 3004, and may not include material in the central segment region 3083 of the central vertical portion relative to the continuous covering 3001. To save material cost. Preferably, the second side of the film has a layered structure which allows the first layer to pass through the void 3011 while the second layer remains between the back cover 3001 and the middle body 3004 . This secures the membranes 3002, 3003 into the back covering 3001. Furthermore, it is preferred that the central body 3004 comprises recesses in which the first sides of the membranes 3002 , 3003 rest, thereby securing them to the central body 3004 . In an alternative configuration, films 3002 and 3003 may be co-molded to back cover 3001 in a multiple molding process.
本领域技术人员要理解的是，歧管的各个部件可以通过使用任何合适的手段而结合或固定在一起。在一个实施方案中，中部体和背部覆盖物之间的密封通过超声焊接或粘合剂来实现。可选地，还可以采用激光焊接。前部覆盖物以相似的方式结合到中部体的另一侧。在一个实施方案中，泵管路节段被溶剂结合就位，或者在可选择的实施方案中，节段可以通过使用塑料中吸收激光的添加剂而被激光焊接。Those skilled in the art will appreciate that the various components of the manifold may be joined or secured together using any suitable means. In one embodiment, the seal between the midbody and the back covering is achieved by ultrasonic welding or adhesives. Optionally, laser welding can also be used. The front covering is joined to the other side of the midbody in a similar fashion. In one embodiment, the pump tubing segments are solvent bonded in place, or in an alternative embodiment, the segments may be laser welded using laser absorbing additives in the plastic.
在一个实施方案中，前部覆盖物由BASFTerlux2802HD，ABS模制，其是透明的并且将提供至流体路径的可见度。ABS的透明性还将提供用于检查超声焊接表面完整性的手段。对于其生物相容性以及对超声焊接的相容性来说，ABS是优选的。此外，前部覆盖物可以包括模制入的有纹路表面来帮助促进前部覆盖物与中部体之间的更好结合。这种有纹路表面是本领域技术人员已知的化学蚀刻工艺。一个优选的纹路深度是0.0045”。其它合适的纹路也可以被激光蚀刻。要被焊接在前部覆盖物上的表面被设计为具有0.003”凹陷部，这转化成在模具上的被提升0.003”的表面。这提供精确的用于接收纹路的表面。一旦成纹路(texturing)在模具上发生，则该0.003”表面的高度就下降。因为0.0045”纹路深度的峰和谷，所以假设平均值将是该量的一半或0.00225”。结果将会使模具在0.00075”的很安全的条件下。覆盖物3005还可以以仅中央竖直部分3090的形式，并且不包括顶部和底部水平部分309l、3092。通过将中央竖直部分3090放置在由中部体3004的与面向覆盖物300l的表面相反的表面上的提升的边缘所限定的凹陷区域中，并且将部分3090结合在凹陷区域内，可以将中央竖直部分3090附接到中部体3004。In one embodiment, the front cover is molded from BASF Terlux 2802HD, ABS, which is transparent and will provide visibility to the fluid path. The transparency of ABS will also provide a means for inspecting the integrity of the ultrasonically welded surface. ABS is preferred for its biocompatibility and compatibility with ultrasonic welding. Additionally, the front cover may include a molded-in textured surface to help promote a better bond between the front cover and the midbody. Such a textured surface is a chemical etching process known to those skilled in the art. A preferred texture depth is 0.0045". Other suitable textures can also be laser etched. The surface to be welded on the front cover is designed to have a 0.003" recess which translates to a raised 0.003" on the mold surface. This provides a precise surface for receiving texturing. Once texturing occurs on the mold, the height of this 0.003" surface drops. Because of the peaks and valleys of the grain depth at 0.0045", it is assumed that the average will be half that amount or 0.00225". The result would be a very safe condition for the mold at 0.00075". The cover 3005 could also be in the form of only the central vertical section 3090 and not include the top and bottom horizontal sections 3091, 3092. By placing the central vertical section 3090 In the recessed area defined by the raised edge on the surface of the central body 3004 opposite the surface facing the cover 3001, and incorporating the portion 3090 within the recessed area, the central vertical portion 3090 can be attached to the central body 3004.
在一个实施方案中，前部覆盖物提供在动脉通道和静脉通道二者中的血液流动导向器。这些特征被设计为尽量减小溶血。血液流动导向器提供贯穿通路的一致的横截面积，并且尽量减小在没有血液流动导向器存在时血液将与其接触的锋利边缘。在血液流动导向器的相反侧上的壁已经被减轻成提供在模制塑料部分中的更一致的壁厚。这将防止在该区域下沉，下沉可能会影响围绕的焊接表面。在一个实施方案中，前部覆盖物壁厚是0.075”。In one embodiment, the front covering provides blood flow directors in both the arterial and venous channels. These features are designed to minimize hemolysis. The blood flow director provides a consistent cross-sectional area throughout the pathway and minimizes sharp edges that blood would come into contact with in the absence of the blood flow director. The walls on the opposite side of the blood flow director have been lightened to provide a more consistent wall thickness in the molded plastic part. This will prevent sinking in this area, which could affect the surrounding weld surface. In one embodiment, the front cover wall thickness is 0.075".
可选地，前部覆盖物具有对准孔，对准孔被提供用于组装目的，以确保前部覆盖物和中部体在超声焊接过程期间被精确地对准。围绕对准孔的提升的凸台帮助尽量增大与焊接夹具的对准销的接触，使得塑料不因摩擦而容易熔化。这些凸台不接触并且不被焊接至中部体，以确保孔是开放的。Optionally, the front cover has alignment holes provided for assembly purposes to ensure that the front cover and mid-body are accurately aligned during the ultrasonic welding process. The raised bosses surrounding the alignment holes help maximize contact with the alignment pins of the soldering jig so that the plastic does not tend to melt due to friction. These bosses do not touch and are not welded to the midbody to ensure that the holes are open.
图3l提供本发明紧凑歧管的中部体部件的透视图。如图31所示，血液透析/血液滤过系统的完全血液和透析液流动路径3101被模制到中部体中。用于血液净化系统的各个功能元件例如泵、阀和传感器的容纳部也被集成到紧凑歧管的中部体片段中。Figure 31 provides a perspective view of the mid-body component of the compact manifold of the present invention. As shown in Figure 31, the complete blood and dialysate flow path 3101 of the hemodialysis/hemofiltration system is molded into the midbody. The accommodations for the individual functional elements of the blood purification system, such as pumps, valves and sensors, are also integrated into the central body section of the compact manifold.
中部体可以由BASFTerlux2802HD，ABS模制。另一个可选择的ABS是Lustran348，White。ABS由于其生物相容性以及对超声焊接的相容性而被选择。中部体与前部覆盖物共同地提供用于歧管的流体路径通道。中部体包含用于对接接头型式的超声焊接的能量导向器。在一个实施方案中，能量导向器的尺寸是0.019”高和宽基部0.024”。这导致0.00023平方英寸的横截面积。焊接表面的宽度是0.075”，导致约0.003”×0.075”的焊接体积。对接接头型式的能量导向器相对于其他型式例如剪切接头、企口缝、阶式接头是优选的，这是由于其简单性和控制模制零件几何的能力。通气孔设置在焊缝几何中，以防止截留的气体被迫通过焊缝，导致可能泄漏的差焊缝。The central body can be molded from BASFTerlux2802HD, ABS. Another optional ABS is Lustran 348, White. ABS was chosen for its biocompatibility and compatibility with ultrasonic welding. The midbody and the front cover together provide fluid path channels for the manifold. The midbody contains energy directors for butt joint style ultrasonic welding. In one embodiment, the dimensions of the energy director are 0.019" high and 0.024" wide base. This results in a cross-sectional area of 0.00023 square inches. The width of the weld surface is 0.075", resulting in a weld volume of approximately 0.003" x 0.075". Butt joint style energy directors are preferred over other styles such as shear joints, grooved joints, stepped joints due to their Simplicity and the ability to control the geometry of the molded part.Vent holes are provided in the weld geometry to prevent trapped gas from being forced through the weld, resulting in a poor weld that could leak.
中部体的背部覆盖物侧优选地提供模制入的有纹路表面，以帮助促进背部覆盖物和中部体之间的更好结合。这种有纹路表面是本领域技术人员已知的化学蚀刻工艺。优选的纹路深度是0.0045”。其它合适的纹路也可以被激光蚀刻。要被焊接在中部体上的表面设计为具有0.003”凹陷部，这转化成在模具上的被提升0.003”的表面。一旦成纹路在模具上发生，则该0.003”表面的高度就下降。因为0.0045”纹路深度的峰和谷，所以假设平均值将是该量的一半或0.00225”。结果将会使模具在0.00075”的很安全的条件下。The back cover side of the mid-body preferably provides a molded-in textured surface to help promote a better bond between the back cover and the mid-body. Such a textured surface is a chemical etching process known to those skilled in the art. The preferred texture depth is 0.0045". Other suitable textures can also be laser etched. The surface to be welded on the midbody is designed to have a 0.003" recess, which translates into a raised 0.003" surface on the mold. Once As texturing occurs on the mold, the height of the 0.003" surface drops. Because of the peaks and valleys of the grain depth at 0.0045", it is assumed that the average will be half that amount or 0.00225". The result will be a very safe condition for the mold at 0.00075".
正被焊接的部件的大小可能对超声焊接过程的成功具有主要影响。如果表面积越大，那么焊接过程就越困难。重要的是，焊接表面被精确地控制。前部覆盖物和背部覆盖物的一致厚度比平坦性更加重要，因为略微不平坦的覆盖物将在焊接过程期间被压平。中部体上的平坦性很重要，这是由于将会防止其在焊接过程期间得以平坦化的结构设计。由于这些问题，非常重要的是，零件被正确地设计并且不易于遭受异常，例如翘曲、下沉、尺寸偏差等等。此外，模具构造及品质需要匹配零件将需要满足的高标准。这将遵循模制过程控制以及将要求最高标准。The size of the parts being welded can have a major impact on the success of the ultrasonic welding process. If the surface area is larger, then the welding process is more difficult. It is important that the welding surface is precisely controlled. Consistent thickness of the front and back coverings is more important than flatness, as slightly uneven coverings will be flattened during the welding process. Flatness on the mid-body is important due to the structural design which will prevent it from being flattened during the welding process. Due to these issues, it is very important that the parts are properly designed and not prone to anomalies such as warping, sinking, dimensional deviations, etc. In addition, mold construction and quality need to match the high standards the parts will need to meet. This will follow molding process controls and will demand the highest standards.
背部覆盖物可以由BASFTerlux28021HD，ABS模制。背部覆盖物包含用于对接接头型式的超声焊接的能量导向器。能量导向器的尺寸是0.019”高，宽基部为0.024”。这导致0.00023平方英寸的横截面积。焊接表面的宽度是0.075”，导致约0.003”×0.075”的焊接体积。该0.003”焊接体积应当在确定组装的部件的几何时被考虑。通气孔设置在焊缝几何中来防止截留的气体被迫通过焊缝，导致可能泄漏的差焊缝。背部覆盖物中的对准孔被提供用于组装的目的，以确保背部覆盖物在超声焊接过程期间被精确地对准至中部体。背部覆盖物中的对准孔还提供在被适当加载时歧管和仪器的精确对准。围绕对准孔的提升的凸台被设计为尽量增大与焊接夹具的对准销的接触，使得塑料不因摩擦而易于熔化。这些凸台不接触并且不被焊接来确保洞是开放的。The back cover can be molded from BASFTerlux28021HD, ABS. The back covering contains energy directors for butt joint style ultrasonic welding. The energy director measures 0.019" high by 0.024" wide at the base. This results in a cross-sectional area of 0.00023 square inches. The width of the weld surface is 0.075", resulting in a weld volume of approximately 0.003" x 0.075". This 0.003" weld volume should be considered when determining the geometry of the assembled parts. Vent holes are provided in the weld geometry to prevent trapped gas from being forced through the weld, resulting in a poor weld that could leak. Alignment holes in the back covering are provided for assembly purposes to ensure that the back covering is accurately aligned to the midbody during the ultrasonic welding process. Alignment holes in the back cover also provide precise alignment of the manifold and instruments when properly loaded. The raised bosses surrounding the alignment holes are designed to maximize contact with the alignment pins of the welding jig so that the plastic does not tend to melt due to friction. These bosses do not touch and are not soldered to ensure that the holes are open.
超声焊接被选择作为用于结合歧管三个主要部件的方法，因为这种制造工艺的成本很低。相对低的设备成本和用于产生焊缝的周期时间归因于这种较低的制造成本。一旦零件被装入夹具，则具有角行进和移除的焊接循环可以在几秒内实现。实际的焊接时间约为一秒。其他的结合方法包括热板、激光和UV粘合剂。Ultrasonic welding was chosen as the method for joining the three main components of the manifold due to the low cost of this manufacturing process. Relatively low equipment costs and cycle times for producing welds are attributed to this low manufacturing cost. Once the part is loaded into the fixture, a welding cycle with corner travel and removal can be performed in seconds. The actual welding time is about one second. Other bonding methods include hot plates, lasers, and UV adhesives.
参照图3l，在一个实施方案中，中部体片段3l00具有集成在其内的三个二通阀3107、五个压力换能器3106、一个闭塞探测器、一个空气泡探测器和一个血液泄漏探测器。本领域技术人员要理解的是，集成在中部体片段3l00内的功能部件的数量和类型可以根据血液净化系统的要求和应用而变化，因此可以包括l、2、3、4、6、7、8、9、10或更多个压力换能器，l、2、4、5、6或更多个二通阀，0、2、3、4或更多个闭塞探测器，0、2、3、4或更多个空气泡探测器，0、2、3、4或更多个血液泄漏探测器。此外，中部体片段3l00包括多个端口3103、3104。Referring to Figure 31, in one embodiment, the mid-body segment 3100 has integrated therein three 2-way valves 3107, five pressure transducers 3106, an occlusion detector, an air bubble detector, and a blood leak detector device. Those skilled in the art will understand that the number and types of functional components integrated in the central body segment 3100 may vary according to the requirements and applications of the blood purification system, and thus may include 1, 2, 3, 4, 6, 7, 8, 9, 10 or more pressure transducers, 1, 2, 4, 5, 6 or more two-way valves, 0, 2, 3, 4 or more occlusion detectors, 0, 2, 3, 4 or more air bubble detectors, 0, 2, 3, 4 or more blood leak detectors. Furthermore, the mid-body segment 3100 includes a plurality of ports 3103,3104.
端口包括内部端口3104，流体经由泵节段(未示出)从并且在歧管3l00的第一节段和第二节段之间流过该内部端口。在一个实施方案中，第一节段具有四个内部端口3104，在第一节段和连接节段连接处的点的每侧上为两个。应当理解的是，第一节段可以具有l、2、3、5、6、7或更多个内部端口。在一个实施方案中，第二节段具有四个内部端口3104，在第二节段和连接节段连接处的点的每侧上为两个。应当理解的是，第二节段可以具有l、2、3、5、6、7或更多个内部端口。此外，优选的是，第一节段的内部端口的位置和地点与第二节段的内部端口的位置和地点镜像。端口还包括至歧管3l00外部的元件的外部端口3103。在一个实施方案中，第一节段具有两个外部端口3103。在一个实施方案中，第二节段具有十个外部端口3104。在一个实施方案中，第一节段具有l、3、4、5、6、7、8、9、10、11、12、13、14、15或更多个外部端口3103。在一个实施方案中，第二节段具有l、2、3、4、5、6、7、8、9、11、12、13、14、15或更多个外部端口3104。The ports include an internal port 3104 through which fluid flows from and between the first and second segments of the manifold 3100 via a pump segment (not shown). In one embodiment, the first segment has four internal ports 3104, two on each side of the point where the first segment and the connecting segments connect. It should be understood that the first segment may have 1, 2, 3, 5, 6, 7 or more internal ports. In one embodiment, the second segment has four internal ports 3104, two on each side of the point where the second segment connects to the connecting segments. It should be understood that the second segment may have 1, 2, 3, 5, 6, 7 or more internal ports. Furthermore, it is preferred that the position and location of the internal ports of the first segment mirror those of the internal ports of the second segment. Ports also include external ports 3103 to elements external to the manifold 3100. In one embodiment, the first segment has two external ports 3103 . In one embodiment, the second segment has ten external ports 3104 . In one embodiment, the first segment has 1, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 or more external ports 3103. In one embodiment, the second segment has 1, 2, 3, 4, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15 or more external ports 3104.
如上文描述，将流体接触元件结合到歧管中，使得能够设计这样的系统，也就是可重复使用的传感器安装在透析机中，歧管与其匹配同时必需地一次性流体接触元件被分离出来并且被放置在歧管中。为了确保作出合适的读数和测量，流体接触元件和可重复使用的传感器需要被对准。歧管和透析机之间的匹配和对准对于定位和所施加的压力至关重要。通常，这样的匹配精确性必须提供在X、Y和Z方向上的0.00l”至0.010”公差，并且施加在10—100PSI的范围内的安装力来与歧管的流体力对抗。这种关键定位通过与透析机上的互补定位表面匹配的、在歧管上的特别设计的定位表面来实现。通过透析机结构的分析和设计以在操作期间在歧管内发展的所有流体及机械压力下允许小于约0.00l”至0.010”的X和Y位置和Z方向偏转来递送所需要的力。因为歧管在一个单块基板上包含许多结构，所以这种关键对准仅需要进行一次，用于将歧管的所有特征与透析机的所有匹配的特征定位。Incorporating the fluid contact elements into the manifold, as described above, enables the design of systems where reusable sensors are installed in the dialysis machine to which the manifold is fitted while the necessary disposable fluid contact elements are separated and placed in the manifold. To ensure proper readings and measurements are made, the fluid contact elements and reusable sensors need to be aligned. Matching and alignment between the manifold and the dialysis machine is critical for positioning and applied pressure. Typically, such mating accuracy must provide tolerances of 0.001" to 0.010" in the X, Y and Z directions, and apply installation forces in the range of 10-100 PSI to counteract the fluid forces of the manifold. This critical positioning is achieved by specially designed positioning surfaces on the manifold that mate with complementary positioning surfaces on the dialysis machine. The required force is delivered by analysis and design of the dialysis machine structure to allow less than about 0.001" to 0.010" of X and Y position and Z deflection under all fluid and mechanical pressures developed within the manifold during operation. Because the manifold contains many structures on a single substrate, this critical alignment only needs to be done once, positioning all features of the manifold with all mating features of the dialysis machine.
中部体通道大小标称地在0.190”深乘以0.190”宽的范围内，在中部体侧上的通道底部拐角的半径为0.020”。在通道底部拐角的半径应当尽可能地大以防止下沉发生在通道壁下方。这些通道壁具有在中部体的相反侧上的阀和压力膜片几何，这可能受到这些区域中的下沉不利地影响。在一个实施方案中，流体路径是方形的。用于防止下沉的一般设计规则是肋部(在这种情况下是通道壁)的壁厚应当不多于其所附接到的相邻壁的50-60％。通道壁是0.075”并且相邻壁(主要歧管结构)是0.130”，导致为58％。0.190”×0.190”透析液通道经过孔过渡至0.155”管路端口。这尽量减小为了将前部覆盖物对准至中部体所需的精确度，并且尽量减小由较厚壁所产生的下沉的潜在可能，该下沉可能会影响中部体相反侧上的密封特征。相同方法被用于抗凝剂和输注液通道。柔和的曲线被设计到通道中，以尽量增大层流且尽量减小紊流。在一个实施方案中，如下文讨论，抗凝剂和输注液通道测量的尺寸是0.190”深乘以0.100”宽。The midbody channel size is nominally in the range of 0.190" deep by 0.190" wide with a radius of 0.020" at the bottom corner of the channel on the midbody side. The radius at the bottom corner of the channel should be as large as possible to prevent subsidence Occurs below the channel walls. These channel walls have valve and pressure diaphragm geometries on opposite sides of the midbody, which can be adversely affected by subsidence in these areas. In one embodiment, the fluid paths are square. A general design rule for preventing subsidence is that the wall thickness of the rib (in this case the channel wall) should be no more than 50-60% of the adjacent wall to which it is attached. The channel wall is 0.075" and The adjacent wall (main manifold structure) is 0.130", resulting in 58%. The 0.190" x 0.190" dialysate channels transition through the holes to the 0.155" tubing ports. This minimizes the precision required to align the front covering to the midbody and minimizes the potential for sinkage created by the thicker walls, which could affect the Sealing feature. The same method was used for the anticoagulant and infusion fluid channels. Gentle curves are designed into the channels to maximize laminar flow and minimize turbulent flow. In one embodiment, as discussed below, the anticoagulant and infusate channels measure 0.190" deep by 0.100" wide.
在一个实施方案中，中部体具有用于组装目的的对准孔，以确保前部覆盖物和背部覆盖物二者在超声焊接工艺期间被精确地对准至中部体。围绕对准孔的提升的凸台尽量增大与焊接夹具的对准销的接触，使得塑料不因摩擦而易于熔化。这些凸台不接触并且不被焊接来确保洞是开放的。In one embodiment, the mid-body has alignment holes for assembly purposes to ensure that both the front and back covers are accurately aligned to the mid-body during the ultrasonic welding process. The raised bosses surrounding the alignment holes maximize contact with the alignment pins of the welding jig so that the plastic does not tend to melt due to friction. These bosses do not touch and are not soldered to ensure that the holes are open.
图33是详细描述根据本发明一个实施方案的用于紧凑歧管的流体回路的图解。流体回路包括与顶部控制器单元内的泵和顶部控制器单元门中的泵靴压力连通的四个泵管节段P1330l、P23302、P33303和P43304。其还包括与压力传感器S13305、S23306、S33307、S43308和S53309压力连通的五个压力膜以及与温度传感器S63310热或光学连通的区域。在图33所示的实施方案中，三对膜VlA和V1B33311、V2A和V2B33312以及V3A和V3B33313集成到歧管中。膜在它们由来自控制器单元的销、构件或突出部闭塞时用作阀。Figure 33 is a diagram detailing a fluid circuit for a compact manifold according to one embodiment of the present invention. The fluid circuit includes four pump tubing segments P13301, P23302, P33303, and P43304 in pressure communication with the pump inside the top controller unit and the pump shoe in the top controller unit door. It also includes five pressure diaphragms in pressure communication with pressure sensors S13305, S23306, S33307, S43308 and S53309 and a region in thermal or optical communication with temperature sensor S63310. In the embodiment shown in Figure 33, three pairs of membranes V1A and V1B33311, V2A and V2B33312, and V3A and V3B33313 are integrated into the manifold. The membranes act as valves when they are occluded by pins, members or protrusions from the controller unit.
成对的六个单向阀3311A、B，3312A、B，3313A、B以这种方式分组，形成三个二通阀组件3311、3312、3313。二通阀提供在控制回路配置方面的更大的灵活性。当常规的二通阀用于闭塞部分流体路径时，它们通常配置成使两个不同的流体路径成为可能，一个用于第一阀状态，一个用于第二阀状态。如下文所公开，与集成到歧管中的阀膜或压力点组合使用的某些阀实施方案使得能够进行更精细地控制，使得能够产生四个分别不同的流体流动路径。Pairs of six one-way valves 3311A, B, 3312A, B, 3313A, B are grouped in this manner to form three two-way valve assemblies 3311, 3312, 3313. Two-way valves provide greater flexibility in control loop configuration. When conventional two-way valves are used to occlude a portion of a fluid path, they are typically configured to enable two distinct fluid paths, one for the first valve state and one for the second valve state. As disclosed below, certain valve embodiments used in combination with valve membranes or pressure points integrated into the manifold enable finer control enabling four respectively distinct fluid flow paths.
泵管节段330l、3302、3303、3304结合到紧凑歧管中。多个端口设置在歧管中，其与歧管外部的管子连接，以允许各种流体流入和流出歧管。这些端口连接到血液净化系统中的各个管子来携带如下的流体：The pump tubing segments 3301, 3302, 3303, 3304 are incorporated into a compact manifold. A number of ports are provided in the manifold that connect with tubing on the outside of the manifold to allow the flow of various fluids into and out of the manifold. These ports connect to the various tubing in the blood purification system to carry fluids such as:
端口A3315—至透析器3330的血液；Port A 3315 - blood to dialyzer 3330;
端口B3316—透析器输出(使用过的透析液)；Port B3316 - dialyzer output (used dialysate);
端口C3317—来自患者的血液；Port C3317 - blood from patient;
端口D3318—用于在血液中混合的肝素；Port D3318—for heparin mixed in blood;
端口E3319—储液器输出(新鲜的透析液)；Port E3319—reservoir output (fresh dialysate);
端口F3320—透析器输入(新鲜的透析液)；Port F3320 - dialyzer input (fresh dialysate);
端口G3321—透析器输出(血液)；Port G3321 - dialyzer output (blood);
端口H3322—患者返回(清洁血液)；Port H3322 - patient return (clean blood);
端口J3323—连接到主管线和排放管线；Port J3323—connects to main and discharge lines;
端口K3324—储液器输注液输入；Port K3324—reservoir infusion solution input;
端口M3325—来自输注液储液器的输注液进入；Port M3325—infusion fluid entry from infusion fluid reservoir;
端口N3326—流到吸附剂中的透析液。Port N3326 - dialysate flow to sorbent.
在一个实施方案中，形成为模制到歧管结构3300中的路径的管子节段将经由端口D3318进入的肝素3314的流体流连接到经由端口C3317进入的血液的流体流。组合的肝素和血液经由泵节段330l流过端口3317a，并且进入歧管3300的端口3317b。压力换能器与形成在歧管结构3300中的膜3305物理连通，膜3305进而使血液和肝素流体穿过端口A3315。在端口A3315从歧管3300出来的流体流动穿过歧管3300外部的透析器3330。透析过的血液通过端口G332l传递返回到歧管3300中并且进入节段3307，该节段形成为模制到歧管结构3300中的路径，该路径与压力换能器物理连通。流体然后从该节段穿过端口H3322并进入患者返回管线。In one embodiment, tube segments formed as pathways molded into the manifold structure 3300 connect the fluid flow of heparin 3314 entering via port D3318 to the fluid flow of blood entering via port C3317. The combined heparin and blood flow through pump segment 3301 through port 3317a and into port 3317b of manifold 3300 . The pressure transducer is in physical communication with a membrane 3305 formed in the manifold structure 3300 which in turn allows blood and heparin fluid to pass through port A 3315 . Fluid exiting the manifold 3300 at port A 3315 flows through a dialyzer 3330 external to the manifold 3300 . Dialyzed blood passes back into manifold 3300 through port G3321 and enters segment 3307, which is formed as a pathway molded into manifold structure 3300 that is in physical communication with the pressure transducer. Fluid then passes from this segment through port H3322 and into the patient return line.
另外，透析流体从储液器经由端口E3319进入歧管3300。储液器中的流体在其中具有输注液，输注液首先经由端口M3325进入歧管3300，穿过形成为模制到歧管结构3300中的路径的节段，穿过另一端口3325a，穿过与泵连通的节段3302，并且经由端口33251b返回到歧管3300中。输注液穿过形成为模制到歧管结构3300中的路径的节段，并且在端口K3324从歧管3300出来，在该端口处其传递进入储液器中。经由端口E3319进入歧管的透析流体穿过形成为模制到歧管结构3300中的路径的节段，穿过另一端口3319a，穿过与泵连通的节段3303，并且经由端口3319b返回到歧管3300中。Additionally, dialysis fluid enters the manifold 3300 from the reservoir via port E3319. The fluid in the reservoir has the infusion therein, which first enters the manifold 3300 via port M3325, passes through the segment formed as a path molded into the manifold structure 3300, passes through another port 3325a, Passes through segment 3302 in communication with the pump and returns into manifold 3300 via port 33251b. The infusate passes through the segment formed as a path molded into the manifold structure 3300 and exits the manifold 3300 at port K 3324 where it passes into the reservoir. Dialysis fluid entering the manifold via port E3319 passes through a segment formed as a path molded into the manifold structure 3300, through another port 3319a, through a segment 3303 that communicates with the pump, and returns via port 3319b to Manifold 3300.
透析液流体传递进入与一对阀3311物理连通的、形成为模制到歧管结构3300中的路径的节段中。形成为模制到歧管结构3300中的路径的节段将透析液流体传递至另一对阀3313。该节段与压力换能器3308和可选的温度传感器3310物理连通。透析液流体通过端口F3320从歧管3300传递出来，并且进入传递到透析器3330中的管线中。Dialysate fluid is communicated into segments formed as pathways molded into manifold structure 3300 in physical communication with a pair of valves 3311 . Segments formed as pathways molded into manifold structure 3300 deliver dialysate fluid to another pair of valves 3313 . This segment is in physical communication with a pressure transducer 3308 and an optional temperature sensor 3310 . Dialysate fluid passes out of manifold 3300 through port F3320 and into a line that passes into dialyzer 3330 .
从透析器3330出来的管线将流体通过端口B3316传递返回到歧管3300中，并且进入与第一对阀3311、第二对阀3312以及压力换能器3306物理连通的、形成为模制到歧管结构3300中的路径的节段。使用过的透析液流体通过端口3326b从歧管3300传递出来，通过与泵连通的节段3304，并且经由端口3326a返回到歧管中。与端口3326a流体连通的节段与压力换能器3309物理连通，并且将流体穿过端口N3326并传递至吸附剂再生系统。Lines coming out of the dialyzer 3330 pass fluid back into the manifold 3300 through port B 3316 and into a valve formed molded into the manifold in physical communication with the first pair of valves 3311, the second pair of valves 3312, and the pressure transducer 3306. Segments of paths in tube structure 3300 . Spent dialysate fluid passes out of manifold 3300 through port 3326b, through segment 3304 in communication with the pump, and back into the manifold via port 3326a. A segment in fluid communication with port 3326a is in physical communication with pressure transducer 3309 and passes fluid through port N3326 and to the sorbent regeneration system.
端口被设计用于回路管路0.268”×0.175”管路或抗凝剂和输注液管路0.16l”×0.135”。优选地，管路端口采用合适的溶剂结合。Ports are designed for return line 0.268" x 0.175" tubing or anticoagulant and infusion fluid lines 0.16l" x 0.135". Preferably, the tubing ports are bonded with a suitable solvent.
应当理解的是，图33中所示的阀3311、3312、3313可以定位在歧管内的不同位置。参照图86，阀8611(图33中的阀3311)可以定位在毗邻于并且平行于阀8612(图33中的阀3312)的歧管8600的中央竖直部分8650。阀8613(图33中的阀3313)也在歧管8600的中央竖直部分8650上，其将顶部水平部分8630和底部水平部分8640连接在一起。阀8613在中央竖直部分8650的底部部分上，并且定位成大致在阀8611、8612下方并且位于它们之间的中央。It should be understood that the valves 3311, 3312, 3313 shown in Figure 33 may be positioned at various locations within the manifold. Referring to FIG. 86 , valve 8611 (valve 3311 in FIG. 33 ) can be positioned in a central vertical portion 8650 of manifold 8600 adjacent to and parallel to valve 8612 (valve 3312 in FIG. 33 ). Valve 8613 (valve 3313 in FIG. 33 ) is also on central vertical section 8650 of manifold 8600, which connects top horizontal section 8630 and bottom horizontal section 8640 together. The valve 8613 is on the bottom portion of the central vertical section 8650 and is positioned approximately below and centrally between the valves 8611, 8612.
在一个实施方案中，二通阀通过使安装在仪器上的阀致动器将弹性体膜片在火山密封部(volcanoseal)上压缩来操作，以防止透析液流过其相应的路径，如下文更详细地描述。火山密封部开口的直径约为0.190”，以匹配通道几何。通过阀内部的横截面路径在阀打开时至少等效于0.190”直径。当阀处于关闭位置时，阀致动器和弹性体膜片消耗围绕火山密封部的流体路径空间的大部分，尽量减小空气滞留的潜在可能。在中部体上具有提升的塑料特征，其尽量减小流体路径内的死空间，以及有助于防止膜片在负压力条件下围绕中心流体路径塌陷。弹性体膜片具有围绕其周长的装配到中部体表面上的沟槽中的O型环特征。O型环被压缩在中部体与背部覆盖物之间，以形成流体密闭的密封部。该设计提供在O型环上的约30％压缩。二通阀控制透析液流过歧管的方向。In one embodiment, the two-way valve operates by causing an instrument-mounted valve actuator to compress an elastomeric diaphragm over a volcanoseal to prevent dialysate flow through its respective pathway, as described below described in more detail. The diameter of the volcano seal opening is approximately 0.190" to match the channel geometry. The cross-sectional path through the interior of the valve is at least equivalent to a 0.190" diameter when the valve is open. When the valve is in the closed position, the valve actuator and elastomeric diaphragm consume the majority of the fluid path space around the volcano seal, minimizing the potential for air entrapment. There is a raised plastic feature on the center body that minimizes dead space within the fluid path and helps prevent the diaphragm from collapsing around the center fluid path under negative pressure conditions. The elastomeric diaphragm has an O-ring feature around its perimeter that fits into a groove on the midbody surface. An O-ring is compressed between the mid-body and back covering to form a fluid-tight seal. This design provides approximately 30% compression on the O-ring. A two-way valve controls the direction of dialysate flow through the manifold.
歧管包含通过使用仪器中的传感器而允许监视整个膜片上流体压力的结构。流体被允许从中部体的前部覆盖物侧上的通道流动通过在背部覆盖物侧上的膜片下方的入口孔和出口孔。通过压力感测结构内部的横截面路径是至少等效于0.190”。内部路径被设计为尽量减小空气滞留，同时提供与膜片足够的流体接触。弹性体膜片具有围绕其周长的装配到中部体表面上的沟槽中的O型环特征。O型环被压缩在中部体和背部覆盖物之间以形成流体密闭的密封部。该设计提供在O型环上的30％压缩。The manifold contains structures that allow monitoring of fluid pressure across the diaphragm through the use of sensors in the instrumentation. Fluid is allowed to flow from channels on the front cover side of the mid-body through inlet and outlet holes beneath the membrane on the back cover side. The cross-sectional path through the interior of the pressure sensing structure is at least equivalent to 0.190". The interior path is designed to minimize air entrapment while providing adequate fluid contact with the diaphragm. The elastomeric diaphragm has a fit around its perimeter O-ring feature into the groove on the mid-body surface. The O-ring is compressed between the mid-body and back cover to form a fluid-tight seal. This design provides 30% compression on the O-ring.
阀和膜片可以由多种不同的材料以及通过不同的工艺制造。在一个实施方案中，弹性体部件由硅树脂制造。在另一个实施方案中，弹性体部件由多种热塑性弹性体制造。二次模制可以用于将阀和膜片附接到背部覆盖物。阀和膜片的二次模制将不再需要将这些零件单独组装到歧管中，因此减少人工成本并且改进歧管组件的品质。Valves and diaphragms can be manufactured from many different materials and by different processes. In one embodiment, the elastomeric part is made of silicone. In another embodiment, the elastomeric component is fabricated from a variety of thermoplastic elastomers. Overmolding may be used to attach the valve and diaphragm to the back cover. Overmolding of the valves and diaphragms would eliminate the need for separate assembly of these parts into the manifold, thus reducing labor costs and improving the quality of the manifold assembly.
歧管设计中的泵送部件已被限定为PVC集管管路。这些集管与仪器的旋转蠕动泵送系统相组合提供血液、透析液和输注液的流动。用于透析液、输注液和抗凝剂的回路管路材料优选地是抗扭结的，例如被Natvar和所有的TEKNIplex公司挤压成型的被称为Colorite，UnichemPTN780，(80A硬度)的管路。用于透析液管线的管路尺寸范围为从0.268”×0.189”至0.268”×0.175”。The pumping components in the manifold design have been defined as PVC header piping. These headers, in combination with the instrument's rotary peristaltic pumping system, provide the flow of blood, dialysate, and infusate. The circuit tubing material for dialysate, infusion and anticoagulants is preferably kink resistant, such as extruded tubing called Colorite, Unichem PTN 780, (80A durometer) by Natvar and all TEKNIplex companies . Tubing sizes for dialysate lines range from 0.268" x 0.189" to 0.268" x 0.175".
为了使歧管节段通过弹性膜与一个或多个传感器有效的热、光学或压力连通，重要的是产生至感测设备的足够紧邻暴露的流体流动。图34中示出了这么做的一种方法。歧管节段3400接收流体流3410，其由于流体路径3410内的突出部、构件或其他结构3408的阻挡和再导向位置而被导致向上运动。流体向上运动并且集中在膜3405和结构3408之间，由此使得能够改进感测。然而，这样的实施方案具有导致血液凝块形成在弯曲部340l、3415或因负压带来的膜3405的基部3406粘附至结构3408的顶部3407而造成的闭塞的潜在可能。In order for the manifold segment to be in effective thermal, optical or pressure communication with one or more sensors through the elastic membrane, it is important to create fluid flow in close proximity to the sensing device in sufficient proximity. One way of doing this is shown in FIG. 34 . Manifold segment 3400 receives fluid flow 3410 that is caused to move upward due to the blocking and redirected position of protrusions, members, or other structures 3408 within fluid pathway 3410 . The fluid moves upwards and collects between the membrane 3405 and the structure 3408, thereby enabling improved sensing. However, such an embodiment has the potential to cause blood clots to form at the bends 3401, 3415 or occlusion due to adhesion of the base 3406 of the membrane 3405 to the top 3407 of the structure 3408 due to negative pressure.
下面同时参照图35A和35B，为了尽量减小血液凝块或闭塞的潜在可能，因此是优选的是，通过弹性膜3505与一个或多个传感器热、光学或压力连通的歧管节段3500(也被称为感测节段)的结构被设计成避免产生会增加凝块或闭塞的可能性的急转弯、弯曲部或U形路径，而仍然提供在流动流体与定位在节段上或紧邻其的传感器之间的足够接触。参照图35A和35B，内部流体路径3515现在由顶部表面和底部表面限定，顶部表面包括膜3505，传感器可以通过该膜而被置于与通过路径3515出现的热、光学或压力连通，底部表面由以下限定：a)沿着壁3525的长度从第一高度至第二高度减小路径3515高度的第一向上倾斜壁3525，b)在第二高度保持相同路径高度3515的平面节段3526，以及c)在整个壁3527的长度上再次从第二高度向下至第一高度增加路径3515高度的向下倾斜壁3527。壁3525、3527的有角度的向上倾斜/向下倾斜使流体路径3515变窄。然而同时，节段的由倾斜壁3525、3527和平面节段3526限定的宽度在该感测节段之前和之后相对于歧管部分增宽。感测节段的相对于在感测节段之前和之后的歧管节段的高度减小和宽度增加提供流体的大致恒定的速度，从而避免可能将血液溶血的速度变化，消除死空间以及保持低雷诺数，同时仍提供用于传感器通过其进行测量的柔性膜3505的所需接触面积。在一个实施方案中，一个或多个柱子3535结合到流体路径3515中，在平面表面3526的顶部以及在膜3505下方以防止因负压导致的膜3505的完全塌陷。Referring now to FIGS. 35A and 35B simultaneously, in order to minimize the potential for blood clots or occlusion, it is therefore preferred that the manifold segment 3500 ( Also referred to as sensing segments) are designed to avoid sharp turns, bends, or U-shaped paths that would increase the likelihood of clots or occlusions, while still providing a connection between the flowing fluid and the sufficient contact between its sensors. 35A and 35B, the internal fluid pathway 3515 is now defined by a top surface comprising a membrane 3505 through which a sensor may be placed in thermal, optical or pressure communication through the pathway 3515, and a bottom surface defined by a bottom surface. The following are defined: a) a first upwardly sloped wall 3525 that decreases the height of the path 3515 from a first height to a second height along the length of the wall 3525, b) a planar segment 3526 that maintains the same path height 3515 at the second height, and c) A downwardly sloping wall 3527 that increases the height of the path 3515 again from the second height down to the first height over the entire length of the wall 3527. The angled up/down slope of the walls 3525, 3527 narrows the fluid path 3515. At the same time, however, the width of the segment defined by the sloped walls 3525, 3527 and the planar segment 3526 widens relative to the manifold portion before and after the sensing segment. The reduction in height and increase in width of the sensing segment relative to the manifold segment preceding and following the sensing segment provides a substantially constant velocity of the fluid, thereby avoiding velocity variations that could hemolyze the blood, eliminating dead space, and maintaining Low Reynolds number while still providing the required contact area for the flexible membrane 3505 through which the sensor makes measurements. In one embodiment, one or more posts 3535 are incorporated into fluid pathway 3515, on top of planar surface 3526 and below membrane 3505 to prevent complete collapse of membrane 3505 due to negative pressure.
从上述讨论要理解的是，歧管的血液及透析回路可以由单件模制塑料件限定，而不是焊接在一起的多个塑料部件。然而，当血液及透析回路由单一整体件材料限定时，会带来某些挑战。特别地，图33中的端口3317b、3317a、3319b、3319a、3325a、3325b、3326a和3326b对于成本有效并且可靠的模制来说具有挑战性，如果限定每个端口的圆柱形形状的突出部从歧管表面直接地垂直地延伸，或者换句话说，以距圆柱形的突出部所附接到的歧管的部分的侧部大致呈零度倾斜。如果端口以完全垂直的配置制造，则来自模制机器的销不能被很容易地除去。同时参照图33和36，优选的是，通过使限定端口结构3655的圆柱形突出部相对于突出部3655附接到的歧管3645(如由表面3675限定)的侧部倾斜来制造端口3317b、3317a、3319b、3319a、3325a、3325b、3326a和3326b。因此，在一个实施方案中，内部歧管端口将相对于歧管表面倾斜。该角度进一步减少在任何被插入两个倾斜端口之间的泵管子节段上的应力。其进一步将泵管子节段定位为处于略微弯曲的、屈曲的或以其他方式非线性的形状以更好地依从泵集管接触表面。在一个实施方案中，由法向于倾斜端口中心的线和法向于歧管侧部的线限定的角度小于20度并且优选地小于10度。在一个实施方案中，该角度是约10度。在一个实施方案中，内部歧管端口3317b、3317a、3319b、3319a、3325a、3325b、3326a、和3326b以上文提到的角度制造，同时其余端口以近似等于零的角度制造。在另一个实施方案中，突出部3655(虽然被描述为是圆柱形的)具有内部区域或容积3753，其中基部3754是大致平面的而不是弯曲的，同时限定容积3753的内结构的其余部分保持是弯曲的3756，如图37所示。在另一个实施方案中，所有的端口或流体路径具有内部区域或容积3753，其中基部3754是大致平面的而不是弯曲的。It should be understood from the above discussion that the blood and dialysis circuits of the manifold may be defined by a single piece of molded plastic rather than multiple plastic parts welded together. However, certain challenges arise when the blood and dialysis circuits are defined by a single, monolithic piece of material. In particular, ports 3317b, 3317a, 3319b, 3319a, 3325a, 3325b, 3326a, and 3326b in FIG. The manifold surface extends directly perpendicular, or in other words, at approximately zero degree inclination from the side of the portion of the manifold to which the cylindrical protrusion is attached. If the ports are manufactured in a completely vertical configuration, the pins from the molding machine cannot be easily removed. Referring to FIGS. 33 and 36 concurrently, the port 3317b is preferably fabricated by slanting the cylindrical protrusion defining the port formation 3655 with respect to the side of the manifold 3645 (as defined by the surface 3675 ) to which the protrusion 3655 is attached. 3317a, 3319b, 3319a, 3325a, 3325b, 3326a, and 3326b. Thus, in one embodiment, the internal manifold ports will be angled relative to the manifold surface. This angle further reduces stress on any section of pump tubing inserted between the two angled ports. It further positions the pump tubing segments in a slightly curved, buckled or otherwise non-linear shape to better conform to the pump header contacting surfaces. In one embodiment, the angle defined by a line normal to the center of the angled port and a line normal to the side of the manifold is less than 20 degrees and preferably less than 10 degrees. In one embodiment, the angle is about 10 degrees. In one embodiment, internal manifold ports 3317b, 3317a, 3319b, 3319a, 3325a, 3325b, 3326a, and 3326b are made at the angles noted above, while the remaining ports are made at angles approximately equal to zero. In another embodiment, protrusion 3655 (although depicted as being cylindrical) has an interior region or volume 3753 wherein base 3754 is generally planar rather than curved, while the remainder of the inner structure defining volume 3753 remains is curved 3756, as shown in Figure 37. In another embodiment, all of the ports or fluid pathways have an interior region or volume 3753 where the base 3754 is generally planar rather than curved.
歧管的另一个实施方案在图38至40中示出，其中血液和透析液流动路径模制在单一紧凑的塑料单元中。在一个实施方案中，歧管3800是容易组装的具有内置的模制血液和废物流动路径的紧凑塑料单元。可选地，传感器、泵和血液滤器盒也可以通过插入到单元中的凹形模制部中而与紧凑的塑料单元集成。在一个实施方案中，本发明的透析系统能够每次处理操作多于8小时并且连续操作达72小时。应当理解的是，流体通过被限定的入口端口和出口端口流入和流出歧管，例如至外部泵和从外部泵，至废物UF储液器，或至患者返回管线。Another embodiment of a manifold is shown in Figures 38 to 40, where the blood and dialysate flow paths are molded into a single compact plastic unit. In one embodiment, the manifold 3800 is an easily assembled compact plastic unit with built-in molded blood and waste flow paths. Optionally, the sensor, pump and hemofilter cassette can also be integrated with the compact plastic unit by being inserted into female moldings in the unit. In one embodiment, the dialysis system of the present invention is capable of operating for more than 8 hours per treatment and for up to 72 hours of continuous operation. It should be understood that fluid flows into and out of the manifold through defined inlet and outlet ports, for example to and from an external pump, to a waste UF reservoir, or to a patient return line.
图39示出了本发明一个实施方案中的歧管3900的模块化组件。泵送片段3930分别包括血液及废物泵3903、3913。模块3940包括用于血液和超滤液废物的模制的流动路径3942和包括血液滤器盒3908的血液滤器模块3950。这种模块化设计允许各个模块快速容易地组装成单一的紧凑结构。Figure 39 illustrates the modular assembly of a manifold 3900 in one embodiment of the invention. The pumping section 3930 includes blood and waste pumps 3903, 3913, respectively. Module 3940 includes molded flow paths 3942 for blood and ultrafiltrate waste and a hemofilter module 3950 including hemofilter cartridge 3908 . This modular design allows the individual modules to be quickly and easily assembled into a single compact structure.
图40示出了图39的中部体模块3940的放大视图。在一个实施方案中，中部体模块4040包括用于携带血液和废物的内置的模制的流动路径4041。连接部端口4042也被模制到中部体模块中，用于连接(经由鲁尔连接器和管路)到在中部体模块4040一个端部的泵以及连接到在中部体模块4040另一个端部的血液滤器盒。FIG. 40 shows an enlarged view of the central body module 3940 of FIG. 39 . In one embodiment, the mid-body module 4040 includes a built-in molded flow path 4041 for carrying blood and waste. A connection port 4042 is also molded into the mid-body module for connection (via a Luer connector and tubing) to a pump at one end of the mid-body module 4040 and to a pump at the other end of the mid-body module 4040 blood filter cartridge.
返回参照图38，血液通过使用与歧管管子节段压力连通的血液容积泵3803经由血液入口端口380l和模制的流动路径3802而被吸入歧管3800中。血液容积泵3803将血液经由模制的流动路径3804泵送到血液滤器盒3808中。入口压力传感器区域3806、3807也在模制的流动路径3802、3804中集成到歧管3800中。Referring back to FIG. 38 , blood is drawn into the manifold 3800 through the blood inlet port 3801 and the molded flow path 3802 using a blood volume pump 3803 in pressure communication with the manifold tube segments. Blood volumetric pump 3803 pumps blood into hemofilter cassette 3808 via molded flow path 3804 . Inlet pressure sensor areas 3806, 3807 are also integrated into manifold 3800 in molded flow paths 3802, 3804.
返回参照图38，来自渗透区3809的废物由废物容积泵3813通过模制的流动路径3814而被抽出，在一个实施方案中，模制的流动路径3814具有在线位于流动路径3814的集成的压力传感器区域3815。废物被泵送通过模制的流动路径3816，在一个实施方案中，模制的流动路径3816具有与从歧管3800通过废物出口端口3819引出的流动路径3816在线的集成的血液泄漏探测器区域3817和废物流量计3818。Referring back to FIG. 38, waste from the permeate zone 3809 is drawn by a waste volumetric pump 3813 through a molded flow path 3814 which, in one embodiment, has an integrated pressure sensor in-line in the flow path 3814 Area 3815. Waste is pumped through a molded flow path 3816 which, in one embodiment, has an integrated blood leak detector region 3817 in-line with the flow path 3816 leading from the manifold 3800 through the waste outlet port 3819 and Waste Flow Meter 3818.
在一个实施方案中，血液滤器盒3808是一次性的，并且可拆卸地集成到歧管3800中的相应模制凹陷部中来完成超滤回路。歧管3800还提供至冗余夹管阀的接口连接，以防止空气进入患者的血管系统。夹管阀设计成使得其在没有电功率被施加时处于关闭(闭塞)位置。In one embodiment, hemofilter cartridge 3808 is disposable and is removably integrated into a corresponding molded recess in manifold 3800 to complete the ultrafiltration circuit. Manifold 3800 also provides an interface to redundant pinch valves to prevent air from entering the patient's vasculature. A pinch valve is designed such that it is in a closed (occluded) position when no electrical power is applied.
模制的流动路径3802、3804、3810、3814和3816限定歧管3800的血液及超滤液流动回路。在一个实施方案中，这些流动路径包括一次性管路和多个适于血液及超滤液接触达至少3日的接口连接部件，例如接头。接头优选地被设计为具有至少5lbs强度和至600mmHg的密封(即大于血液滤器最大跨膜压力)。在一个实施方案中，对应于流动路径3802、3804和3810的血液套件管路具有用于供应50ml/分钟血液流动的合适长度和内径。在一个实施方案中，血液套件管路(包括血液滤器)的主要容积小于40ml。血液套件管路与血液容积泵3803接口连接。在一个实施方案中，血液泵3803管路是Tygon牌的，型号S-50-HL，大小l/8”内径×3/16”外径×l/32”壁。Molded flow paths 3802 , 3804 , 3810 , 3814 , and 3816 define the blood and ultrafiltrate flow circuits of manifold 3800 . In one embodiment, the flow paths include disposable tubing and a plurality of interfacing components, such as fittings, suitable for contacting blood and ultrafiltrate for at least 3 days. The joint is preferably designed to have a strength of at least 5 lbs and a seal to 600 mmHg (ie greater than the hemofilter maximum transmembrane pressure). In one embodiment, blood set tubing corresponding to flow paths 3802, 3804, and 3810 has a suitable length and inner diameter for supplying a blood flow of 50 ml/min. In one embodiment, the primary volume of the blood set tubing (including the hemofilter) is less than 40ml. The blood set pipeline is connected with the blood volume pump 3803 interface. In one embodiment, blood pump 3803 tubing is Tygon brand, model S-50-HL, size 1/8" ID x 3/16" OD x 1/32" wall.
类似地，在一个实施方案中，对应于流动路径3814和3816的超滤液套件管路能够供应500ml/小时(8.33ml/分钟)的超滤液流动。超滤液套件管路还与废物容积泵3813接口连接。在一个实施方案中，废物泵3813管路是Tygon牌的，型号为S-50-HL，大小3/32”内径×5/32”外径×l/32”壁。Similarly, in one embodiment, the ultrafiltrate set tubing corresponding to flow paths 3814 and 3816 is capable of supplying an ultrafiltrate flow of 500 ml/hour (8.33 ml/minute). The ultrafiltrate kit tubing is also interfaced with a waste volumetric pump 3813. In one embodiment, waste pump 3813 tubing is Tygon brand, model S-50-HL, size 3/32" ID x 5/32" OD x 1/32" wall.
因为本发明的歧管包括用于血液、透析液、废物流体和置换液的模制的流动路径，所以整个的流动路径可以作为便携式复合歧管被很容易地制造。歧管还易于操纵，因为所有的在歧管外侧的柔性管路附接在歧管的一侧上。使用具有内置的模制的流动路径的歧管增强防故障的处理，因为断开、不正确装配和泄漏的可能性与使用许多柔性管路的现有技术系统相比被尽量减小。使用新颖歧管还增强易用性，导致便携性得到增强。Because the manifold of the present invention includes molded flow paths for blood, dialysate, waste fluid, and replacement fluid, the entire flow path can be easily fabricated as a portable composite manifold. The manifold is also easy to handle since all the flexible tubing outside the manifold is attached on one side of the manifold. The use of manifolds with built-in molded flow paths enhances fail-safe handling as the potential for disconnection, improper fitting and leaks is minimized compared to prior art systems that use many flexible tubing. Use of the novel manifold also enhances ease of use, resulting in enhanced portability.
在一个实施方案中，透析歧管是独立的紧凑单元，使得它们可以被独立且单独地用于处理来自患者的血液。在另一个实施方案中，两个歧管可连接到彼此，以用作二阶段血液处理系统。在一个示例中，血液被从患者中的动脉部位抽取，并且被传递通过透析器，在透析器中大量的废物流体被对流出来。歧管用于将等量的流体返回至血液，然后再输注血液。歧管测量废物流体并且将废物流体倾泻到废物袋中。In one embodiment, the dialysis manifolds are self-contained compact units such that they can be used independently and individually to process blood from a patient. In another embodiment, two manifolds may be connected to each other for use as a two-stage blood treatment system. In one example, blood is drawn from an arterial site in a patient and passed through a dialyzer where a large volume of waste fluid is convected. The manifold is used to return equal volumes of fluid to the blood before infusing the blood. A manifold measures waste fluid and dumps waste fluid into a waste bag.
如本领域技术人员已知的是，血液滤器或透析器、盒3808包括中空管子，中空管子还包括其壁用作半渗透膜的多个中空纤维管。所述多个半渗透的中空纤维管将血液滤器盒3808分成在中空纤维管内的血液流动区3805和在中空纤维管外的过滤或渗透区3809。随着血液穿过血液区3805，血浆水(plasmelwater)传递跨过中空纤维管的半渗透膜。血液滤器盒3808是小的血液滤器。更浓缩的血液通过模制的流动路径3810从盒3808流动出来并且通过血液出口端口3811从歧管3800流动出来。空气探测器区域3812也被集成到血液返回流动路径3810中。As is known to those skilled in the art, the hemofilter or dialyzer, cassette 3808, comprises a hollow tube which also comprises a plurality of hollow fiber tubes whose walls act as semi-permeable membranes. The plurality of semi-permeable hollow fiber tubes divides the hemofilter cartridge 3808 into a blood flow zone 3805 inside the hollow fiber tubes and a filtration or permeate zone 3809 outside the hollow fiber tubes. As the blood passes through the blood zone 3805, plasma water passes across the semi-permeable membrane of the hollow fiber tube. Hemofilter cartridge 3808 is a small blood filter. More concentrated blood flows out of cassette 3808 through molded flow path 3810 and out of manifold 3800 through blood outlet port 3811 . An air detector area 3812 is also integrated into the blood return flow path 3810 .
以下是根据本发明一个实施方案的血液滤器或透析器3808的示例性物理规格：The following are exemplary physical specifications of a hemofilter or dialyzer 3808 according to one embodiment of the invention:
在透析治疗期间，患者或护理提供者将上文描述的歧管之一安装在透析机中。参照图4l，透析机410l具有可以被宽地打开以安装一次性部件的前部门4103。为了安装，歧管4104简单地需要插在被提供用于在透析单元4101中的目的的空间中，如之前所讨论。安装透析器4102还涉及在指定凹陷部中的简单插入。前部门4103设置有泵靴4105，该泵靴使一次性部件的加载非常容易，因为不需要任何泵管路穿过滚动器与靴之间。此外，这种布置允许以确保相对非一次性部件例如压力读取器、传感器及其它部件合适对准的方式安装透析器4102和歧管4104。这种成套简单的方法使得能够很容易地一次性加载和清洁系统。其还确保流动回路被适当地配置且易于使用。During a dialysis treatment, a patient or care provider installs one of the manifolds described above in a dialysis machine. Referring to Figure 41, a dialysis machine 4101 has a front door 4103 that can be opened wide to install disposable components. For installation, the manifold 4104 simply needs to be plugged into the space provided for its purpose in the dialysis unit 4101, as previously discussed. Installing the dialyzer 4102 also involves simple insertion in a designated recess. The front door 4103 is provided with a pump shoe 4105 which makes loading of the disposables very easy as there is no need for any pump lines to pass between the roller and the shoe. Furthermore, this arrangement allows the dialyzer 4102 and manifold 4104 to be mounted in a manner that ensures proper alignment relative to non-disposable components such as pressure readers, sensors, and others. This packaged simplicity makes it easy to load and clean the system in one go. It also ensures that the flow circuit is properly configured and easy to use.
参照图42，在一个实施方案中，歧管4202安装在透析系统420l的竖直前部面板4203上。歧管4202由多个对准机构精确地定位在该面板4203上。第一对准机构包括在面板4203中的接合歧管4202中的对准孔的多个对准销。第二对准机构包括至少一个闩锁，其将歧管4203保持在特定的安装位置，直到门4206关闭且获得最终的精确位置。在一个实施方案中，歧管4202的背部覆盖物具有在顶部和底部的两个被设计在内的凸台。在门4206关闭之前，这些凸台将歧管4202闩锁在第一保持位置，且随后将歧管4202放置在精确位置。凸台使可以被手动或被要求使用手强制除去歧管4202的球棘爪释放的闩锁机构成为可能。在另一个实施方案中，闩锁机构包括在背部覆盖物的顶部的弹簧加载的插入和释放机构。该机构具有在顶部闩锁和底部闩锁之间的连接杆。当在顶部的释放机构被激活时，底部闩锁也被释放。Referring to Figure 42, in one embodiment, a manifold 4202 is mounted on a vertical front panel 4203 of a dialysis system 4201. The manifold 4202 is precisely positioned on the panel 4203 by a plurality of alignment mechanisms. The first alignment mechanism includes a plurality of alignment pins in faceplate 4203 that engage alignment holes in manifold 4202 . The second alignment mechanism includes at least one latch that holds the manifold 4203 in a specific installed position until the door 4206 is closed and the final precise position is achieved. In one embodiment, the back cover of the manifold 4202 has two built-in bosses on the top and bottom. These bosses latch the manifold 4202 in the first holding position before the door 4206 is closed, and subsequently place the manifold 4202 in a precise position. The bosses enable a latch mechanism that can be released manually or by a ball detent that requires the use of the hand to forcibly remove the manifold 4202. In another embodiment, the latch mechanism includes a spring-loaded insertion and release mechanism on the top of the back cover. The mechanism has a connecting rod between the top and bottom latches. When the release mechanism on the top is activated, the bottom latch is also released.
第三对准机构包括引导歧管4202的大体位置和配置的仿形引导器4208。仿形引导器4208优选地成形为匹配或以其他方式补充歧管4202的物理结构。在一个实施方案中，引导器4208大体上为矩形，并且配置成装配在由歧管4202的第一节段、第二节段和连接节段约束的空间内部，如上文描述。第四对准机构包括门4206，该门具有至少一个弹簧加载的压力板4205，该压力板将歧管4202捕获在门4206和前部面板4203之间，从而施加对于阀调和压力传感来说足够的压力。门4206还包括四个压力靴，这些压力靴将足够的压力施加至泵送部件用于流体的旋转蠕动递送。The third alignment mechanism includes a contoured guide 4208 that guides the general location and configuration of the manifold 4202 . Contoured guides 4208 are preferably shaped to match or otherwise complement the physical structure of manifold 4202 . In one embodiment, the guide 4208 is generally rectangular and is configured to fit inside the space bounded by the first, second, and connecting segments of the manifold 4202, as described above. The fourth alignment mechanism includes a door 4206 with at least one spring-loaded pressure plate 4205 that captures the manifold 4202 between the door 4206 and the front panel 4203, thereby applying pressure for valve adjustment and pressure sensing. enough stress. The door 4206 also includes four pressure shoes that apply sufficient pressure to the pumping components for rotational peristaltic delivery of fluid.
应当理解的是，可以使用对准机构中的一个或多个，或单独或组合，以实现用于歧管的所需对准及加压的位置。应当进一步理解的是，对准机构附接到在透析装置包围部内的凹陷区域的表面。凹陷区域包括前部面板4203，其相对于透析装置外壳凹陷并且由四个壁(第一壁、第二壁、第三壁和第四壁)约束，其从前部面板4203向上延伸以接触并且牢固地附接到透析装置包围部。凹陷部足够深，并且配置成接收门4206。It should be appreciated that one or more of the alignment mechanisms may be used, alone or in combination, to achieve the desired aligned and pressurized position for the manifold. It should be further understood that the alignment mechanism is attached to the surface of the recessed area within the enclosure of the dialysis device. The recessed area includes a front panel 4203 that is recessed relative to the dialysis device housing and bounded by four walls (first, second, third, and fourth walls) that extend upwardly from the front panel 4203 to contact and secure securely attached to the dialysis device enclosure. The recess is sufficiently deep and configured to receive the door 4206 .
传感系统sensor system
如上文所述，透析系统特别是顶部控制器单元包括传感系统，传感系统与部分歧管特别是歧管的透明部分或内嵌在歧管结构中的膜相互作用，以感测某些参数或状态，例如流量、温度、压力、钠的存在、氨的存在、pH水平、泄漏的血液、闭塞或空气泡。例如，对血液泄漏、空气泡和/或闭塞的感测是通过将附接到并且围绕歧管预定区域的光学传感器包括在透析机中来实现的。歧管可以包括多个管路支撑支架，其便于在歧管被安装且门被关闭时将回路管路精确地放置到被分离安装在仪器中的光学传感器例如Optek传感器中。传感器提供用于探测动脉管线中的闭塞、在透析器下游的血液管线中的血液泄漏以及静脉血液管线中的空气探测的手段。支架将管路束缚在传感器的一侧上，同时管路端口进行在传感器的另一侧上的束缚。这些光学传感器是U形装置，管路在歧管被安装时被推入该U形装置中。管路支撑支架提供对管路的支撑，使得所有的三个这些传感器以与加载歧管相同的运动来加载，而没有额外的努力在用户的部分上。用于流量、温度、断开、中央静脉压的传感系统以及其他系统将在下文进一步描述。As mentioned above, the dialysis system, particularly the top controller unit, includes a sensing system that interacts with a portion of the manifold, particularly the transparent portion of the manifold or a membrane embedded in the manifold structure, to sense certain Parameters or conditions such as flow, temperature, pressure, presence of sodium, presence of ammonia, pH level, leaking blood, occlusion or air bubbles. For example, sensing of blood leaks, air bubbles, and/or occlusions is accomplished by including optical sensors in the dialysis machine that are attached to and surround predetermined areas of the manifold. The manifold may include a plurality of tubing support brackets that facilitate precise placement of the return tubing into optical sensors, such as Optek sensors, mounted separately in the instrument when the manifold is installed and the door is closed. The sensors provide means for detecting occlusions in the arterial line, blood leaks in the blood line downstream of the dialyzer, and air detection in the venous blood line. The bracket secures the tubing on one side of the sensor while the tubing port secures on the other side of the sensor. These optical sensors are U-shaped devices into which the tubing is pushed when the manifold is installed. The tubing support bracket provides support to the tubing so that all three of these sensors are loaded with the same motion as the loading manifold, with no extra effort on the user's part. Sensing systems for flow, temperature, disconnect, central venous pressure, and others are described further below.
流量flow
在一个实施方案中，透析系统包括非侵入性或非接触型的声学流量计，其具有在没有物理接触的情况下直接地在待被监视的流体中产生声信号的能力，从而基于声波传送时间的测量提供具有改进精确度的流动测量。进一步设想，本流量计可以与上文描述的歧管之一共同使用，以非侵入地测量歧管内的流动。In one embodiment, the dialysis system includes an acoustic flow meter of the non-invasive or non-contact type, which has the ability to generate an acoustic signal directly in the fluid to be monitored without physical contact, thereby The measurements of provide flow measurements with improved accuracy. It is further contemplated that the present flow meter may be used with one of the manifolds described above to non-intrusively measure flow within the manifold.
图43是描绘了示例性光声流量计4300的电路图。流量待被测量的流体4304由流体承载通路4305(例如管子、管路或歧管节段)在由箭头4306指示的方向携带。光声脉冲流量计4300包括光发射系统4310。在一个实施方案中，系统4310还包括LED或固态激光器4307，其被信号源4308以正弦曲线的方式激发。在另一个实施方案中，Q开关红宝石激光器可以用于代替系统4310。本领域技术人员要理解的是，本领域中已知的任何其他合适的光学产生系统可用于该目的。FIG. 43 is a circuit diagram depicting an exemplary photoacoustic flow meter 4300. A fluid 4304 whose flow is to be measured is carried by a fluid carrying passage 4305 (eg, a tube, tubing, or manifold segment) in the direction indicated by arrow 4306 . Photoacoustic pulse flow meter 4300 includes light emission system 4310 . In one embodiment, the system 4310 also includes an LED or solid state laser 4307 that is excited by a signal source 4308 in a sinusoidal fashion. In another embodiment, a Q-switched ruby laser can be used in place of system 4310. It will be appreciated by those skilled in the art that any other suitable optical production system known in the art may be used for this purpose.
光学产生系统4310将光束4309通过形成在通路4305(即歧管节段)的壁中的光学孔或光学上透明的片段投射到流体4304中。在一个实施方案中，被投射的光束4309在垂直于流体承载通路4305的轴线4312的方向的方向上横贯穿过流体4304。管子4305的光学上透明的片段应当对光源4310的特定波长是透明的。光源4310的波长必须被选择成使得光被系统旨在测量其流量的流体4304容易地吸收。应当进一步理解的是，当该系统4300与歧管共同使用时，光学产生系统4310优选地包含在一次性歧管被加载到其中的透析机中并与歧管对准，使得所产生的光束4309穿过歧管的透明片段。Optical generation system 4310 projects light beam 4309 into fluid 4304 through optical holes or optically transparent segments formed in the walls of passageways 4305 (ie, manifold segments). In one embodiment, the projected light beam 4309 traverses through the fluid 4304 in a direction perpendicular to the direction of the axis 4312 of the fluid-bearing passage 4305 . The optically transparent segment of the tube 4305 should be transparent to the specific wavelength of the light source 4310. The wavelength of the light source 4310 must be chosen such that the light is readily absorbed by the fluid 4304 whose flow the system is intended to measure. It should be further understood that when the system 4300 is used with a manifold, the optical generation system 4310 is preferably contained within the dialysis machine into which the disposable manifold is loaded and aligned with the manifold such that the generated light beam 4309 Transparent segment passing through the manifold.
随着光束4309传入流体4304，与光束相关的热能被吸入到流体中。吸收热沿着光束4309的方向发生并且导致流体4304中的热扰动。这些热扰动作为局部的流体加热出现并且导致流体中的热膨胀。作为这种热膨胀的结果，声信号4311得以产生。在流体4304中的压力变化方面，该信号的特性复制了在用于给光学信号产生元件4307供能的信号源4308中产生的波形。这种压力变化在相对于光束4309的在通路4305中的位置下游和上游传播。As the beam 4309 passes into the fluid 4304, thermal energy associated with the beam is drawn into the fluid. Absorption heat occurs along the direction of the light beam 4309 and causes thermal disturbances in the fluid 4304 . These thermal disturbances occur as localized fluid heating and lead to thermal expansion in the fluid. As a result of this thermal expansion, an acoustic signal 4311 is generated. The characteristics of this signal replicate the waveform produced in the signal source 4308 used to power the optical signal generating element 4307 in terms of pressure changes in the fluid 4304 . This pressure change propagates both downstream and upstream relative to the beam 4309's location in the passage 4305.
如本领域技术人员已知，由传感器4313和4314在上游和下游接收的声信号分别将是彼此不同相的。在上游和下游接收的声信号之间的相位差的量与流量成正比。应当进一步理解的是，当与一次性歧管共同使用时，传感器4313和4314定位成紧邻于歧管管路或内嵌在歧管管路内。As is known to those skilled in the art, the acoustic signals received upstream and downstream by sensors 4313 and 4314, respectively, will be out of phase with each other. The amount of phase difference between the acoustic signals received upstream and downstream is proportional to flow. It should be further understood that when used with a disposable manifold, sensors 4313 and 4314 are positioned proximate to or inline within the manifold tubing.
因此，在一个实施方案中，声探测器T14313和T24314分别放置在上游和下游，距光束4309等距离，使得d14313a和d24314a是相等的。在另一个实施方案中，4313和4314的上游和下游放置不需要是距4309等距的。探测器Tl和T2可以是压力换能器或声换能器例如麦克风。麦克风盒例如由Panasonic公司制造的型号WM—55A103适于本应用。Thus, in one embodiment, acoustic detectors T14313 and T24314 are placed upstream and downstream, respectively, equidistant from beam 4309 such that d14313a and d24314a are equal. In another embodiment, the upstream and downstream placement of 4313 and 4314 need not be equidistant from 4309. The detectors T1 and T2 may be pressure transducers or acoustic transducers such as microphones. A microphone capsule such as model WM-55A103 manufactured by Panasonic Corporation is suitable for this application.
探测器T14313和T24314询问流体流动以探测在探测器T14313和T24314所定位的点处的声信号4311。随着声信号4311的压力变化(声音)通过导管4305的壁传递至传感器4313和4314，询问在听觉上发生。Detectors T14313 and T24314 interrogate the fluid flow to detect the acoustic signal 4311 at the point where the detectors T14313 and T24314 are located. Interrogation occurs audibly as pressure changes (sounds) of acoustic signal 4311 are transmitted through the walls of conduit 4305 to transducers 4313 and 4314 .
第一接收放大器4315连接到探测器T14313，第二接收放大器4316连接成接收来自探测器T24314的输出。第一和第二放大器4315和4316的输出通过增益控制元件4319和4320分别连接到第一和第二相敏探测器4317和4318的输入。相敏探测器4317和4318的一个实施在本领域中称为“锁定放大器”。在信号被放大器4315、4316和相敏探测器4317、4318处理之后，4317和4318的输出穿过低通滤波器432l和4322，以消除来自信号的从相敏探测过程4324留下的高频噪声分量或脉动。滤波器432l和4322的结果输出是代表分别由4313和4314探测到的声信号的相对于发生器4308的原始信号的相对相位的稳定信号。因此，光声流量计提供对上游和下游声信号的相对于基准信号的相位角的指示。The first receiving amplifier 4315 is connected to the detector T1 4313 and the second receiving amplifier 4316 is connected to receive the output from the detector T2 4314. The outputs of the first and second amplifiers 4315 and 4316 are connected through gain control elements 4319 and 4320 to the inputs of the first and second phase sensitive detectors 4317 and 4318 respectively. One implementation of phase sensitive detectors 4317 and 4318 is known in the art as a "lock-in amplifier". After the signal is processed by amplifiers 4315, 4316 and phase sensitive detectors 4317, 4318, the outputs of 4317 and 4318 pass through low pass filters 4321 and 4322 to remove high frequency noise from the signal left over from the phase sensitive detection process 4324 component or pulsation. The resulting output of filters 4321 and 4322 are stable signals representing the relative phase of the acoustic signals detected by 4313 and 4314, respectively, with respect to the original signal from generator 4308. Thus, a photoacoustic flow meter provides an indication of the phase angle of the upstream and downstream acoustic signals relative to a reference signal.
在由相敏探测器元件的处理和相位探测之后，上游和下游相位角信号被供应至加法/减法单元4323。加法/减法单元4323的输出代表由声波探测器T14313在上游和由声波探测器T24314在下游接收到的声信号之间的相位差。这些声信号之间的这种相位差与流体的流量成正比，并且如本领域技术人员要理解的是，可以用作用于计算实际流量或流量改变的基础。所有用于计算流量的手段包括处理器和用于由至少相位差数据导出流量或流量改变的软件算法。因此，加法/减法单元4323的输出提供对流体4304的流量的测量。After processing and phase detection by the phase sensitive detector elements, the upstream and downstream phase angle signals are supplied to the addition/subtraction unit 4323 . The output of the addition/subtraction unit 4323 represents the phase difference between the acoustic signals received upstream by the acoustic wave detector T1 4313 and downstream by the acoustic wave detector T2 4314 . This phase difference between the acoustic signals is directly proportional to the flow rate of the fluid and, as will be understood by those skilled in the art, can be used as a basis for calculating the actual flow rate or change in flow rate. All means for calculating flow include a processor and software algorithms for deriving flow or change in flow from at least phase difference data. Thus, the output of the addition/subtraction unit 4323 provides a measure of the flow of fluid 4304 .
因此，如上文描述，在一个实施方案中，第一和第二低通滤波器432l和4322的输出电压信号被采样，并且在单元4323中经受减法来确定指示通路4305中的流体流量的相位差信号。本领域技术人员要理解的是，任何其他合适的用于由声波探测器的输出计算相位差的手段可以被采用。所有这样的手段包括处理器和用于计算相位差的硬编码或软编码的软件算法。Thus, as described above, in one embodiment, the output voltage signals of the first and second low pass filters 4321 and 4322 are sampled and subjected to subtraction in unit 4323 to determine a phase difference indicative of fluid flow in passage 4305 Signal. It will be appreciated by those skilled in the art that any other suitable means for calculating the phase difference from the output of the acoustic wave detector may be employed. All such means include a processor and a hard-coded or soft-coded software algorithm for calculating the phase difference.
如之前所提到，由源4308产生的信号用作用于上游和下游声换能器T14313和T24314的基准信号。图44描绘了由图43的源4308产生的基准信号4400a。图44分别描绘了在经受在图43分别增益控制放大器4315和4316的输出的信号处理之后的声波信号4400b和4400c。As mentioned before, the signal produced by source 4308 is used as a reference signal for the upstream and downstream acoustic transducers T14313 and T24314. FIG. 44 depicts reference signal 4400a produced by source 4308 of FIG. 43 . Fig. 44 depicts acoustic wave signals 4400b and 4400c, respectively, after being subjected to signal processing at the outputs of gain-controlled amplifiers 4315 and 4316, respectively, of Fig. 43 .
在一个实施方案中，利用光声脉冲流量计来非侵入地监视透析系统例如本领域技术人员已知的血液透析、血液滤过和/或血液透析滤过系统中的流体的流量。透析期间需要测量流量的流体主要是分别在血液和透析液回路中的血液和透析液；然而，本领域技术人员要理解的是，其他流体例如输注液或浓缩液的流量也可以采用本发明的流量计来测量。本领域技术人员还要理解的是，本发明的流量计还能够指示何时在导管/通路中具有不流动的流体。In one embodiment, a photoacoustic pulse flow meter is utilized to non-invasively monitor the flow of fluid in a dialysis system, such as a hemodialysis, hemofiltration and/or hemodiafiltration system known to those skilled in the art. The fluids whose flows need to be measured during dialysis are primarily blood and dialysate in the blood and dialysate circuits respectively; however, those skilled in the art will understand that the flow of other fluids such as infusion fluids or concentrates can also be used with the present invention flow meter to measure. It will also be understood by those skilled in the art that the flow meter of the present invention can also indicate when there is no flowing fluid in the conduit/pathway.
因此，返回参照图43，如果低通滤波器432l和4322的信号输出之间的差是零，则这将暗示没有流体流动。在透析系统应用中，这种对没有流动流体的探测非常有用，因为其可以指示严重的问题例如连接到患者的动脉/静脉导管的断开。Thus, referring back to FIG. 43, if the difference between the signal outputs of low pass filters 4321 and 4322 is zero, this would imply no fluid flow. In dialysis system applications, this detection of no flowing fluid is very useful as it can indicate a serious problem such as a disconnection of the arterial/venous line connected to the patient.
在另一个实施方案中，可以由热流量计测量歧管内的流动。图56示出了与歧管5602共同安装在透析机5610中的本发明的热流体流动测量装置560l。如前面所提到，歧管5602具有内嵌在其内的流体流动路径或管路回路5603。透析机5610具有可以被打开以安装一次性歧管5602的前部门5620。此外，前部门5620配备有引脚562l，其在门5620关闭时可以接触歧管5602上的电气点来读取信息或提供电输入。In another embodiment, the flow within the manifold can be measured by a thermal flow meter. FIG. 56 shows a thermal fluid flow measurement device 5601 of the present invention installed in a dialysis machine 5610 together with a manifold 5602 . As previously mentioned, the manifold 5602 has a fluid flow path or tubing loop 5603 embedded therein. The dialysis machine 5610 has a front door 5620 that can be opened to install a disposable manifold 5602 . Additionally, the front door 5620 is equipped with pins 5621 that can contact electrical points on the manifold 5602 to read information or provide electrical input when the door 5620 is closed.
热流体流动测量装置560l还包括一系列触点5611、5612和5613。操作性地，随着流体(例如血液、透析液或其他流体)在透析期间流过流体流动路径5603，其穿过内嵌在塑料路径中的第一触点5611。触点5611与电力源电接触，在一个实施方案中，电力源是在机器前部门5620上的引脚5621。电力源或引脚由透析机5610中的控制器控制。电力源向触点5611提供电刺激，电刺激用于基于正弦波方法来微加热触点。Thermal fluid flow measurement device 5601 also includes a series of contacts 5611 , 5612 and 5613 . Operationally, as fluid (eg, blood, dialysate, or other fluid) flows through fluid flow path 5603 during dialysis, it passes through first contact 5611 embedded in the plastic path. The contacts 5611 are in electrical contact with a power source, which in one embodiment is a pin 5621 on the front door 5620 of the machine. The power source or pin is controlled by a controller in the dialysis machine 5610. The power source provides electrical stimulation to the contacts 5611, which is used to microheat the contacts based on a sine wave approach.
在一个实施方案中，微加热过程导致在正被测量的流体中0.1至1.0摄氏度之间的温度增加。这借助于位于第一触点5611的微加热器被导致，微加热器在接收电刺激时产生热。用于本发明的热流体流动测量装置的微加热器可以通过使用任何适于本应用的设计而被制造。例如在一个实施方案中，微加热器由围绕位于第一接触位置5611的销缠绕的10匝的30g铜丝制造。In one embodiment, the micro-heating process results in a temperature increase in the fluid being measured of between 0.1 and 1.0 degrees Celsius. This is caused by means of a microheater located at the first contact 5611, which generates heat when receiving an electrical stimulus. Microheaters for use in thermal fluid flow measurement devices of the present invention can be fabricated using any design suitable for the application. For example, in one embodiment, the microheater is fabricated from 10 turns of 3Og copper wire wrapped around a pin at the first contact location 5611.
随着触点5611被微加热，所得到的热能用来产生热波，热波从第一触点5611向下游传播。多个触点(其在一个实施方案中数量为两个—5612和5613)位于从第一触点5611的下游，并且用于测量热波的传播时间。所测量的波相位然后与由第一触点5611产生的初始波进行比较。因此所确定的相位差提供流量的指示。As the contact 5611 is slightly heated, the resulting thermal energy is used to generate a heat wave that propagates downstream from the first contact 5611. A plurality of contacts (which in one embodiment are two in number - 5612 and 5613) are located downstream from the first contact 5611 and are used to measure the travel time of the thermal wave. The measured wave phase is then compared to the initial wave generated by the first contact 5611. The determined phase difference thus provides an indication of flow.
图45示出了具有可用于流动测量的探针的流量计4500a的一个实施方案。通道450la包围流体例如水或盐水溶液(0.9N)4503a流过的容积4502a。在一个实施方案中，通道具有在lmm至5mm的范围内(优选地3mm)的高度，在3mm至13mm的范围内(优选地8mm)的宽度，在10mm至100mm的范围内(优选地50mm)的长度，在3mm2至65mm2的范围内(优选地24mm2)的通道面积，和/或在1.5mm至7.22mm的范围内(优选地4.36mm)的水力直径。Figure 45 shows one embodiment of a flow meter 4500a with a probe that can be used for flow measurements. The channel 4501a encloses a volume 4502a through which a fluid such as water or saline solution (0.9N) 4503a flows. In one embodiment, the channel has a height in the range of 1 mm to 5 mm (preferably 3 mm), a width in the range of 3 mm to 13 mm (preferably 8 mm), in the range of 10 mm to 100 mm (preferably 50 mm) length, a channel area in the range of 3mm2 to 65mm2 (preferably 24mm2 ), and/or a hydraulic diameter in the range of 1.5mm to 7.22mm (preferably 4.36mm).
流体流动的方向由箭头4504a示出。激发探针4505a定位成紧邻于接收器探针4506a。探针的相对距离是设计的重要特征，因为电刺激需要由激发销或探针4505a所递送的激发频率取决于探针4505a和4506a之间的间距。在一个实施方案中，激发探针和接收器探针定位成彼此相距小于2英寸，优选地小于0.8英寸，更优选地约0.6英寸或者约15mm。在本实施方案中，激发和测量仅需要两个触点，每个触点具有接触表面4507a。本领域技术人员要理解的是，在这样的情况下，仅将需要两个接触点，而不是三个，如上文关于一次性歧管和透析机所示。The direction of fluid flow is shown by arrow 4504a. Excitation probe 4505a is positioned in close proximity to receiver probe 4506a. The relative distance of the probes is an important feature of the design because the electrical stimulation required by the excitation pin or the frequency of excitation delivered by the probe 4505a depends on the spacing between the probes 4505a and 4506a. In one embodiment, the excitation and receiver probes are positioned less than 2 inches from each other, preferably less than 0.8 inches, more preferably about 0.6 inches or about 15 mm. In this embodiment, only two contacts are required for excitation and measurement, each having a contact surface 4507a. Those skilled in the art will understand that in such a case only two points of contact would be required, not three, as shown above with respect to the disposable manifold and dialysis machine.
激发销或探针4505a内嵌在通道450la中，并且用于向流动的流体提供热刺激(以热波的形式)，热刺激然后由接收探针4506a感测和测量。在一个实施方案中，销或探针的主体直径在0.03英寸至0.15英寸的范围内(优选地0.08英寸)，顶部接触表面的直径在0.025英寸至0.2英寸的范围内(优选地0.125英寸)，并且由镀金的黄铜或任何其他的具有约8500kg/m3的密度、约1.09W/mK的热导率和/或约0.38J/KgK的比热的材料制成。An activation pin or probe 4505a is embedded in the channel 4501a and is used to provide a thermal stimulus (in the form of a heat wave) to the flowing fluid which is then sensed and measured by the receiving probe 4506a. In one embodiment, the body diameter of the pin or probe is in the range of 0.03 inches to 0.15 inches (preferably 0.08 inches), the diameter of the top contact surface is in the range of 0.025 inches to 0.2 inches (preferably 0.125 inches), And made of gold-plated brass or any other material with a density of about 8500 kg/m3 , a thermal conductivity of about 1.09 W/mK, and/or a specific heat of about 0.38 J/KgK.
在一个实施方案中，激发销或探针4505a和接收销或探针4506a二者的主体模制到歧管中(使得销或探针不与流体物理接触，并且其顶部接触区域暴露于歧管的一个表面)。销或探针的主体在单元格的中心并且流体经过其。销的顶部被暴露，所以来自仪器面板的弹簧加载的触点可以进行热接触，从而使热能能够在弹簧加载的触点和销的接触表面之间的传递。In one embodiment, the bodies of both the firing pin or probe 4505a and the receiving pin or probe 4506a are molded into the manifold (so that the pin or probe is not in physical contact with the fluid and its top contact area is exposed to the manifold. of a surface). The body of the pin or probe is in the center of the cell and the fluid passes through it. The tops of the pins are exposed so that the spring-loaded contacts from the instrument panel can make thermal contact, thereby enabling the transfer of thermal energy between the spring-loaded contacts and the contact surfaces of the pins.
例如，参照图45，示出了本发明的热流量计4500b的一个实施方案的侧视图，其中接触表面4507b被暴露，使得来自透析机的仪器面板的弹簧加载的触点(在图56中示出)可以进行热接触，并且热能可以在弹簧加载的触点和激发销或探针4505b之间交换。通道4501b包围流体4503b流过的容积4502b。流体流动的方向由箭头4504b示出。激发探针4505b定位成紧邻于接收器探针4506b，每个探针具有接触表面4507b。For example, referring to FIG. 45, a side view of one embodiment of a thermal flow meter 4500b of the present invention is shown in which the contact surface 4507b is exposed such that spring-loaded contacts from the instrument panel of the dialysis machine (shown in FIG. 56 out) can make thermal contact and thermal energy can be exchanged between the spring-loaded contact and the firing pin or probe 4505b. Channel 4501b encloses volume 4502b through which fluid 4503b flows. The direction of fluid flow is shown by arrow 4504b. Excitation probes 4505b are positioned in close proximity to receiver probes 4506b, each probe having a contact surface 4507b.
图45还示出了来自流动通道450lc端部的热流量计4500c，该流动通道包含流体4503c流过的容积4502c。在本文中，仅接收器探针4506c及其接触表面4507c被示出。在一个实施方案中，接收触点或销4506c的结构类似于激发销4505b的结构，并且其顶部4507c也被暴露。在一个实施方案中，接收器销表面4507c也被设计为低热质量弹簧加载的触点。激发4505a以及接收器4506a探针或销由合适的具有高热和电传导率的材料制成，其在一个实施方案中是镀金的黄铜。Figure 45 also shows a thermal flow meter 4500c from the end of a flow channel 4501c containing a volume 4502c through which a fluid 4503c flows. Herein, only receiver probe 4506c and its contact surface 4507c are shown. In one embodiment, the receive contact or pin 4506c is similar in structure to the fire pin 4505b, and its top 4507c is also exposed. In one embodiment, the receiver pin surface 4507c is also designed as a low thermal mass spring loaded contact. The excitation 4505a and receiver 4506a probes or pins are made of a suitable material with high thermal and electrical conductivity, which in one embodiment is gold plated brass.
在一个实施方案中，仪器例如透析机中的低热质量弹簧加载的触点通过使用加热器和热敏电阻器被温度控制。温度控制功能然后产生在探针中的余弦温度波形，其反映在弹簧加载的触点中产生的温度波。所得到的作为激发销的特征的激发信号可以被定义为：In one embodiment, low thermal mass spring loaded contacts in an instrument such as a dialysis machine are temperature controlled using heaters and thermistors. The temperature control function then generates a cosine temperature waveform in the probe that mirrors the temperature wave generated in the spring loaded contacts. The resulting fire signal that characterizes the fire pin can be defined as:
es＝Escos(ωt)，其中ωt是激发频率。es =Es cos(ωt), where ωt is the excitation frequency.
接收器销的热响应可以由下式表征：The thermal response of the receiver pin can be characterized by:
rr＝Rrsin(ωt+θ)，其中ωt是激发频率且是相位。rr =Rr sin(ωt+θ), where ωt is the excitation frequency and is the phase.
热波传播的一个代表在图46中示出。参照图46，箭头460l表示通道中的流体路径4602中的流体流动的方向(且因此热波的传播方向)。测量触点由4611、4612和4613表示。因为微加热器定位成紧邻于第一触点4611，所以热波在第一触点初始，并且然后分别朝向位于从第一触点4611下游的第二和第三触点4612和4613传播。第二触点4612和第三触点4613之间的距离是4615。A representative of thermal wave propagation is shown in Figure 46. Referring to FIG. 46, arrow 4601 indicates the direction of fluid flow (and thus the direction of propagation of thermal waves) in fluid path 4602 in the channel. Measurement contacts are indicated by 4611 , 4612 and 4613 . Because the microheater is positioned immediately adjacent to the first contact 4611, the heat wave initiates at the first contact and then propagates towards the second and third contacts 4612 and 4613, respectively, located downstream from the first contact 4611. The distance between the second contact 4612 and the third contact 4613 is 4615 .
图46还示出了在三个触点4611、4612和4613的示例性波动测量4620。在第一触点4611产生的热波由第一曲线462l表示。考虑到流动是从左至右，该热波将略微地在其到达在第三位置的触点4613的时间之前到达在第二位置的触点4612。第二和第三触点4612和4613的输出分别由曲线4622和4623表示。FIG. 46 also shows exemplary fluctuation measurements 4620 at three contacts 4611 , 4612 and 4613 . The heat wave generated at the first contact 4611 is represented by the first curve 4621. Considering that the flow is from left to right, the heat wave will reach the contact point 4612 in the second position slightly before the time it reaches the contact point 4613 in the third position. The outputs of the second and third contacts 4612 and 4613 are represented by curves 4622 and 4623, respectively.
第二信号4622和第三信号4623之间的相移可以通过比较对于每个的零交叉的点而被测量。第二触点4612和第三触点4613之间的距离4615除以相应的零交叉之间的时间(也被称为渡越时间)等于流体的流动速度。此外，将计算出的流动速度乘以流体路径的直径得到体积流量。The phase shift between the second signal 4622 and the third signal 4623 can be measured by comparing the points of zero crossings for each. The distance 4615 between the second contact point 4612 and the third contact point 4613 divided by the time between corresponding zero crossings (also referred to as transit time) is equal to the flow velocity of the fluid. Additionally, multiplying the calculated flow velocity by the diameter of the fluid path yields the volumetric flow rate.
热波可以通过使用温度传感器而被监视，在一个实施方案中，温度传感器由热敏电阻器例如Cantherm零件编号CWF4B153F3470构建，并且放置为与定位在第二和第三位置处的触点物理接触。在一个实施方案中，触点通过使用在透析机本身中的热测量装置(其与两个金属触点接触)而被监视/测量。这不需要将分离的温度测量装置集成在歧管中。应当理解的是，在优选的实施方案中，透析机或非一次性仪器包含处理器和存储器，该存储器记录：a)被通信至在安装一次性歧管是与激发探针的接触表面物理连通的弹簧加载的触点的激发频率，以及b)由接收器探针感测并且通过接收器探针的接触表面而被通信至透析机或非一次性仪器中的弹簧加载的触点的温度波的频率。处理器实施本文描述的推导，以基于上文列出的被存储的数据来确定温度水平和改变。应当进一步理解的是，该温度信息然后被通信至显示驱动器，其促使信息经由用户界面而被视觉显示或听觉传达。The thermal wave can be monitored by using a temperature sensor, in one embodiment constructed from a thermistor such as Cantherm part number CWF4B153F3470, and placed in physical contact with contacts positioned at the second and third locations. In one embodiment, the contacts are monitored/measured by using a thermal measurement device in the dialysis machine itself which makes contact with the two metal contacts. This eliminates the need to integrate a separate temperature measurement device in the manifold. It should be understood that, in a preferred embodiment, the dialysis machine or non-disposable instrument contains a processor and a memory that records: a) is communicated to the contact surface that is in physical communication with the excitation probe when the disposable manifold is installed and b) the temperature wave sensed by the receiver probe and communicated to the spring-loaded contact in the dialysis machine or non-disposable instrument through the contact surface of the receiver probe Frequency of. The processor implements the derivations described herein to determine temperature levels and changes based on the stored data listed above. It should be further understood that this temperature information is then communicated to a display driver which causes the information to be displayed visually or conveyed audibly via the user interface.
在一个实施方案中，探测回路通过混合激发信号和接收器信号、进行比较并且将结果提交至低通滤波器以得到相移信息来检查相移。更特别地，在一个实施方案中，相位探测通过将激发频率乘以接收器信号来实现。结果得到具有两个分量的信号，一个以频率的二倍并且一个是与激发基准信号和接收器信号之间的相移成比例的DC信号。这是通过下式来表示的：In one embodiment, the detection loop checks for phase shift by mixing the excitation and receiver signals, comparing and submitting the result to a low pass filter for phase shift information. More specifically, in one embodiment, phase detection is achieved by multiplying the excitation frequency by the receiver signal. The result is a signal with two components, one at twice the frequency and one being a DC signal proportional to the phase shift between the excitation reference signal and the receiver signal. This is represented by the following formula:
相位探测：
其中，es是激发信号，rr是接收器信号，ωt是激发频率并且是相位。where, es is the excitation signal,rr is the receiver signal, ωt is the excitation frequency and is the phase.
如上文所述，本发明依赖于用于渡越时间测量的波并且不依赖于热脉冲。这种方法提供显著的优点，因为热脉冲扩散，导致在脉冲边缘开始之处的不确定性，并且大大增加测量噪声。波也扩散，但是即使在扩散之后，正弦波的相移仍保持为比较明显。因此，依赖于正弦波来进行测量引入更少的噪声。As stated above, the present invention relies on waves for transit time measurements and not on thermal pulses. This approach offers significant advantages because the thermal pulse spreads out, causing uncertainty in where the pulse edges start and greatly increasing measurement noise. The wave also spreads, but even after spreading, the phase shift of the sine wave remains relatively pronounced. Therefore, relying on sine waves for measurements introduces less noise.
本发明的另一个优点在于将热流量传感器集成在一次性歧管中。在歧管中使用的塑料用作热绝缘体，这有益地实现测量。如之前所提到，在一个实施方案中，弹簧加载的探针用于热流动测量装置，这使其成本很低并且是一次性的。Another advantage of the present invention resides in the integration of thermal flow sensors in disposable manifolds. The plastic used in the manifold acts as a thermal insulator, which advantageously enables the measurement. As previously mentioned, in one embodiment, a spring loaded probe is used for the thermal flow measurement device, which makes it very low cost and disposable.
本发明装置的设计根据三个参数来优化：a)热激发(热输入信号的频率)，b)预期的流量(较低流量需要与较高流量不同的频率，因为较低流量经历更多的扩散)，以及c)热扩散的量和程度。在一个实施方案中，为了尽量减小噪声以及改进探测精确度，人们可以将关键的参数设置为是恒定的，例如恒定的相移、恒定的频率或恒定的流动面积。The design of the device of the present invention is optimized according to three parameters: a) thermal excitation (frequency of the thermal input signal), b) expected flow (lower flow requires a different frequency than higher flow because lower flow experiences more diffusion), and c) the amount and degree of thermal diffusion. In one embodiment, to minimize noise and improve detection accuracy, one can set key parameters to be constant, such as constant phase shift, constant frequency, or constant flow area.
在一个实施方案中，恒定相移方法是通过使用相敏探测器和数字控制的频率发生器来实施的。如上文描述，渡越时间导致激发探针和接收器探针之间的物理延迟。在高流量，物理延迟很小，而在低流量，物理延迟很大。因此，为了保持恒定相移，激发频率通过来自相敏探测器的反馈而被控制。反馈环路包括在系统中，使得重要参数例如激发频率可以被动态调整，使得相移保持恒定。In one embodiment, the constant phase shift method is implemented using a phase sensitive detector and a digitally controlled frequency generator. As described above, transit time results in a physical delay between the excitation probe and the receiver probe. At high traffic, the physical delay is small, while at low traffic, the physical delay is large. Therefore, to maintain a constant phase shift, the excitation frequency is controlled by feedback from the phase sensitive detector. A feedback loop is included in the system so that important parameters such as the excitation frequency can be adjusted dynamically such that the phase shift remains constant.
参照图53，示出了采用恒定相移操作模式的本发明一个实施方案的示意图。流过通道530l的液体5303穿过激发探针5305和接收器探针5307，它们被分隔距离5309，如上文所述。在一个实施方案中，通道530l是被设计为插入到透析机中并且在其内使用的歧管的一部分。一旦安装在透析机内，则激发探针5305的接触表面就热接触加热器驱动器5325且接收器探针5307的接触表面热接触温度传感器5330。加热器驱动器5325和温度传感器5330与在透析机中实施和/或集成在其内的回路电接触。Referring to Figure 53, a schematic diagram of an embodiment of the present invention employing a constant phase shift mode of operation is shown. Liquid 5303 flowing through channel 5301 passes excitation probe 5305 and receiver probe 5307, which are separated by distance 5309, as described above. In one embodiment, channel 5301 is part of a manifold designed to be inserted into and used within a dialysis machine. Once installed within the dialysis machine, the contact surface of the excitation probe 5305 is in thermal contact with the heater driver 5325 and the contact surface of the receiver probe 5307 is in thermal contact with the temperature sensor 5330 . The heater driver 5325 and temperature sensor 5330 are in electrical contact with circuits implemented in and/or integrated within the dialysis machine.
在激发探针侧上，回路包括基准信号源5310，其将具有相位θr的信号传输至求和装置5315，该装置还接收来自低通滤波器的信号输入θm，如下文所述。两个信号被求和、处理、或以其他方式比较以获得输出，该输出被传输至电压控制振荡器5320。电压控制振荡器5320输出信号Rp，其中Rp＝Kpsin(ωt)，信号Rp由加热器驱动器5325接收并且用于驱动加热器驱动器5325以获得被热通信至探针5305的激发波。On the excitation probe side, the loop includes a reference signal source 5310 which transmits a signal with phase θr to a summation device 5315 which also receives a signal input θm from a low pass filter, as described below. The two signals are summed, processed, or otherwise compared to obtain an output, which is transmitted to a voltage controlled oscillator 5320 . The voltage controlled oscillator 5320 outputs a signal Rp, where Rp=Kpsin(ωt), which is received by the heater driver 5325 and used to drive the heater driver 5325 to obtain an excitation wave that is thermally communicated to the probe 5305 .
热波作为流体5303流量的函数传播经过通道530l。接收器探针5307将感测到的热波热通信至温度传感器5330。感测到的热波可以表示为函数，如下表示：Es＝Kssin(ωt+θc)。Thermal waves propagate through channel 5301 as a function of fluid 5303 flow rate. Receiver probe 5307 thermally communicates the sensed heat wave to temperature sensor 5330. The sensed thermal wave can be expressed as a function as follows: Es=Kssin(ωt+θc).
如上文所述，温度传感器5330与在透析机内实施的或集成到其中的回路电接触。感测到的热波(Es)被通信至采用倍增器部件5335的同步相敏探测器，其将感测到的热波(Es)与来自电压控制振荡器5320的输入信号(Rn，其中Rn＝Kncos(ωt))相乘，获得输出信号EsRn。输出信号EsRn(其可以表示为EsRn＝(KnKs/2)[sin(2ωt+θc)+sin(θc)])被输入到放大器5340中并且被放大常数Kl。已放大的信号然后被输入到低通滤波器5345中，其接收来自电压控制振荡器5320的输入信号。来自电压控制振荡器5320的输入信号用于变化低通滤波器5345的滤波阈值或截止频率。来自低通滤波器5345的输出(θm，其可以表示为函数KnKsKlθc/2)是指示流体流量(其可以通过本领域技术人员已知的任何手段被导出)的信号，并且被通信返回至所述求和装置5315，以用于从电压控制振荡器5320产生基准信号。As noted above, the temperature sensor 5330 is in electrical contact with a circuit implemented within or integrated into the dialysis machine. The sensed thermal wave (Es) is communicated to a synchronized phase-sensitive detector employing a multiplier component 5335, which compares the sensed thermal wave (Es) to an input signal (Rn, where Rn =Kncos(ωt)) to obtain the output signal EsRn. An output signal EsRn (which can be expressed as EsRn=(KnKs/2)[sin(2ωt+θc)+sin(θc)]) is input into the amplifier 5340 and amplified by a constant K1. The amplified signal is then input into a low pass filter 5345 which receives the input signal from the voltage controlled oscillator 5320 . The input signal from the voltage controlled oscillator 5320 is used to vary the filter threshold or cutoff frequency of the low pass filter 5345 . The output (θm, which can be expressed as a function KnKsKlθc/2) from the low pass filter 5345 is a signal indicative of fluid flow (which can be derived by any means known to those skilled in the art) and is communicated back to the A summing device 5315 for generating a reference signal from a voltage controlled oscillator 5320 .
图47是图示被动态地调整以保持恒定相移的激发频率的范围的表格。参照图47，确定过程将各种参数的值考虑在内，例如流量470l，其在25至600ml/min之间变化，以及流速4702，其范围从17.36mm/s至416.67mm/s。使用用于探针分离4703的15mm值，激发频率4705将从～1.16Hz25ml/min流量至27.78Hz600ml/min流量变化。行程时间和接收器振幅的相应值分别在行4704和4706中详细描述。要指出的是，接收器振幅对于恒定相移来说维持在零。Figure 47 is a table illustrating the range of excitation frequencies that are dynamically adjusted to maintain a constant phase shift. Referring to Figure 47, the determination process takes into account the values of various parameters such as flow rate 4701, which varies between 25 and 600 ml/min, and flow rate 4702, which ranges from 17.36 mm/s to 416.67 mm/s. Using the 15mm value for probe separation 4703, the firing frequency 4705 will vary from ~1.16Hz 25ml/min flow to 27.78Hz 600ml/min flow. The corresponding values for travel time and receiver amplitude are detailed in rows 4704 and 4706, respectively. Note that the receiver amplitude is maintained at zero for constant phase shift.
图48示出了相敏探测器的输出相对于时间轴4810的曲线图。各种曲线4820表示对于不同流量值的相敏探测器的一系列输出。图48中的图已经绘制出对于在图47的表格中给出的值；因此，流量范围从25至600ml/min并且相应的激发频率从～1.16Hz至27.78Hz变化。FIG. 48 shows a graph of the output of a phase sensitive detector versus time axis 4810 . Various curves 4820 represent a range of outputs from the phase sensitive detector for different flow values. The graph in Figure 48 has been plotted for the values given in the table of Figure 47; thus, flow rates range from 25 to 600ml/min and the corresponding excitation frequencies vary from ~1.16Hz to 27.78Hz.
在另一个实施方案中，相移可以被允许变化，同时频率激发保持恒定。恒定频率激发与相敏探测器被共同采用，而未使用反馈机构。图49示出了详细描述在激发频率4906维持在1.157Hz时的各种参数的值的表格。该值是对于在25至600ml/min之间变化的流量490l以及范围从17.36mm/s至416.67mm/s的流速4902。当探针分离4903设置在15mm时，行程时间4904的相应值范围从0.0360秒(对于1.000的谐波4905值)至0.864秒。变化相移反映在行4907中详细描述的相应接收器振幅值中。接收器振幅4907在最后的行中示出。图50A和50B示出了相敏探测器的输出(对于在图49中指定的流量的范围)的两组相对于时间轴的曲线图。In another embodiment, the phase shift can be allowed to vary while the frequency excitation is kept constant. A constant frequency excitation is used with a phase sensitive detector without the use of a feedback mechanism. Figure 49 shows a table detailing the values of various parameters when the excitation frequency 4906 was maintained at 1.157 Hz. The values are for flow rates 4901 varying between 25 to 600ml/min and flow rates 4902 ranging from 17.36mm/s to 416.67mm/s. When the probe separation 4903 was set at 15 mm, the corresponding values for the travel time 4904 ranged from 0.0360 seconds (for a harmonic 4905 value of 1.000) to 0.864 seconds. The changing phase shift is reflected in the corresponding receiver amplitude values detailed in row 4907. Receiver amplitude 4907 is shown in the last row. Figures 50A and 50B show two sets of plots of the output of the phase sensitive detector (for the range of flows specified in Figure 49) versus time.
参照图54，示出了采用恒定频率操作模式的本发明一个实施方案的示意图。流过通道540l的液体5403经过激发探针5405和接收器探针5407，它们被分隔距离5409，如上文所述。在一个实施方案中，通道540l是被设计为插入到透析机中并且在其内使用的歧管的一部分。一旦安装在透析机内，则激发探针5405的接触表面就热接触加热器驱动器5425，并且接收器探针5407的接触表面热接触温度传感器5430。加热器驱动器5425和温度传感器5430与在透析机中实施和/或集成在其内的回路电接触。Referring to Figure 54, a schematic diagram of an embodiment of the present invention employing a constant frequency mode of operation is shown. Liquid 5403 flowing through channel 5401 passes excitation probe 5405 and receiver probe 5407, which are separated by distance 5409, as described above. In one embodiment, channel 5401 is part of a manifold designed to be inserted into and used within a dialysis machine. Once installed within the dialysis machine, the contact surface of the excitation probe 5405 is in thermal contact with the heater driver 5425 and the contact surface of the receiver probe 5407 is in thermal contact with the temperature sensor 5430 . The heater driver 5425 and the temperature sensor 5430 are in electrical contact with a circuit implemented in and/or integrated within the dialysis machine.
在激发探针侧上，回路包括基准信号源5410，例如正弦发生器，其将具有频率(例如在或约1.17Hz)的信号传输至加热器驱动器5425。正弦发生器5410输出信号Rp，其中Rp＝Kpsin(ωt)，该信号由加热器驱动器5425接收并且用于驱动加热器驱动器5425以获得被热通信至探针5405的激发波。优选的是，激发频率足够低，所以在低流量相移小于80度。正弦发生器5410还输出信号Rn，其中Rn＝Kncos(ωt)，该信号被倍增器5435和低通滤波器5445接收，如下文进一步描述。On the excitation probe side, the loop includes a reference signal source 5410 , such as a sinusoidal generator, which transmits a signal having a frequency (eg, at or about 1.17 Hz) to a heater driver 5425 . The sinusoidal generator 5410 outputs a signal Rp, where Rp=Kpsin(ωt), which is received by the heater driver 5425 and used to drive the heater driver 5425 to obtain an excitation wave that is thermally communicated to the probe 5405 . Preferably, the excitation frequency is low enough so that the phase shift is less than 80 degrees at low flow. Sine generator 5410 also outputs a signal Rn, where Rn=Kncos(ωt), which is received by multiplier 5435 and low pass filter 5445, as described further below.
热波作为流体5403流量的函数传播经过通道540l。接收器探针5407将感测到的热波热通信至温度传感器5430。感测到的热波可以表示如下函数：Es＝Kssin(ωt+θc)。温度传感器5430与在透析机内实施的或集成到其中的回路电接触。感测到的热波(Es)被通信至采用倍增器部件5435的同步相敏探测器，其将感测到的热波(Es)与来自正弦发生器5410的输入信号(Rn，其中Rn＝Kncos(ωt))相乘，获得输出信号EsRn。输出信号EsRn(其可以表示为EsRn＝(KnKs/2)[sin(2ωt+θc)+sin(θc)])被输入到放大器5440中并且被放大常数Kl。已放大的信号然后被输入到低通滤波器5445中，其接收来自正弦发生器5410的输入信号。来自正弦发生器5410的输入信号用于变化低通滤波器5445的滤波阈值或截止频率。来自低通滤波器5445的输出(θm，其可以表示为KnKsKlθc/2的函数)是指示流体的流量(其可以通过本领域技术人员已知的任何手段被导出)的信号。应当理解的是，低通滤波器的频率截止是激发频率的约l/20。低通滤波器应当将2ωt信号衰减至少80db。Thermal waves propagate through channel 5401 as a function of fluid 5403 flow rate. The receiver probe 5407 thermally communicates the sensed heat wave to the temperature sensor 5430. The sensed thermal wave can be represented by the following function: Es=Kssin(ωt+θc). The temperature sensor 5430 is in electrical contact with a circuit implemented within or integrated into the dialysis machine. The sensed thermal wave (Es) is communicated to a synchronized phase-sensitive detector employing a multiplier component 5435, which compares the sensed thermal wave (Es) with an input signal from a sinusoidal generator 5410 (Rn, where Rn = Kncos(ωt)) are multiplied to obtain the output signal EsRn. An output signal EsRn (which can be expressed as EsRn=(KnKs/2)[sin(2ωt+θc)+sin(θc)]) is input into the amplifier 5440 and amplified by a constant K1. The amplified signal is then input into a low pass filter 5445 which receives the input signal from the sine generator 5410 . The input signal from the sine generator 5410 is used to vary the filter threshold or cutoff frequency of the low pass filter 5445 . The output (θm, which can be expressed as a function of KnKsKlθc/2) from the low pass filter 5445 is a signal indicative of the flow rate of the fluid (which can be derived by any means known to those skilled in the art). It should be understood that the frequency cutoff of the low pass filter is about 1/20 of the excitation frequency. The low-pass filter should attenuate the 2ωt signal by at least 80db.
图55示出了采用低流量和高流量在恒定频率模式中产生的信号的相对相移。激发信号5530在时间0被产生。在低流量情况下，感测到的信号5520从激发信号5530偏移θLF的相移5540，而在高流量情况下，感测到的信号5510从激发信号5530偏移θHF的相移5550。Figure 55 shows the relative phase shift of signals generated in constant frequency mode with low flow and high flow. Fire signal 5530 is generated at time 0. During low flow conditions, the sensed signal 5520 is offset from the excitation signal 5530 by a phase shift of θLF 5540, while under high flow conditions the sensed signal 5510 is offset from the excitation signal 5530 by a phase shift of θHF 5550 .
与采用恒定的还是变化的相移方法用于测量无关，使用相移作为流动测量的基础与使用振幅相比是有利的，因为振幅可以受到外部因素例如外部温度影响的影响，外部因素应当不影响相移。Irrespective of whether a constant or varying phase shift method is used for the measurement, the use of phase shift as the basis for flow measurements is advantageous compared to the use of amplitude, which can be influenced by external factors such as external temperature influences, which should not affect phase shift.
在一个实施方案中，本发明的非侵入性的热流体流量计提供20ml/min至600ml/min的测量范围。除上文列出的因素之外，对于为了最优性能设计热流量计来说重要的其它因素包括流动特征例如流态、最大雷诺数和流动速度；以及流动单元格的物理特征，例如通道高度、宽度和长度。In one embodiment, the non-invasive thermal fluid flow meter of the present invention provides a measurement range of 20 ml/min to 600 ml/min. In addition to the factors listed above, other factors important to designing a thermal flow meter for optimal performance include flow characteristics such as flow regime, maximum Reynolds number, and flow velocity; and physical characteristics of the flow cell, such as channel height , width and length.
图5l包括列出了被优化成使得流态保持在层流且雷诺数5109维持低于2000的用于600ml/min的最大流量510l的设计参数的示例性组的表格。为了将流态保持为层流，通道大小(包括通道高度5102、宽度5103、长度5104、面积5105和水力直径5106)被优化。雷诺数5109在将流动速度5107、水力直径5106的值以及水5108的性质例如密度、动态粘度和运动粘度考虑在内之后被计算出。Figure 51 includes a table listing an exemplary set of design parameters for a maximum flow rate 5101 of 600ml/min optimized such that the flow regime remains laminar and the Reynolds number 5109 remains below 2000. To maintain the flow regime as laminar, the channel size (including channel height 5102, width 5103, length 5104, area 5105 and hydraulic diameter 5106) is optimized. The Reynolds number 5109 is calculated after taking into account the values of the flow velocity 5107, hydraulic diameter 5106 and properties of the water 5108 such as density, dynamic viscosity and kinematic viscosity.
在一个实施方案中，流动单元格被设计为用于紊流流态，而不是层流。流动单元格的这种设计导致恒定的流动面积，这进而将涉及围绕探针增宽的流动面积(其对于层流来说围绕探针得以减少)。当在探针的面积增宽时，流体围绕探针在速度上增加并且增加的速度使流态运动成湍流流态。In one embodiment, the flow cell is designed for turbulent flow regimes rather than laminar flow. This design of the flow cell results in a constant flow area, which in turn will involve a widened flow area around the probe (which for laminar flow is reduced around the probe). As the area of the probe widens, the fluid increases in velocity around the probe and the increased velocity moves the flow regime into a turbulent flow regime.
图52是示出了用于激发和接收器探针的示例性设计参数的另一个组的表格，在一个实施方案中，激发和接收器探针的大小被确定成具有为了最优性能的低于l毫秒的热时间常数5205。为此目的而被考虑在内的因素是材料(其在这种情况下是黄铜)及其性质520l，例如密度、热导率和比热以及对流系数5204。因此，探针的大小5202和暴露的表面积5203得以确定。Figure 52 is a table showing another set of exemplary design parameters for excitation and receiver probes, in one embodiment, the excitation and receiver probes are sized to have low Thermal time constant 5205 in 1 millisecond. Factors taken into account for this purpose are the material (which in this case is brass) and its properties 5201 such as density, thermal conductivity and specific heat and convection coefficient 5204 . Thus, the size 5202 and exposed surface area 5203 of the probe is determined.
温度传感temperature sensor
如上文所提到，用于透析系统的紧凑歧管还包括温度传感器。在一个实施方案中，温度传感器定位在储液器组件中。然而，温度传感器还可以定位在储液器组件外部，并且在这样的实施方案中，其可以集成到歧管中。As mentioned above, the compact manifold for the dialysis system also includes a temperature sensor. In one embodiment, the temperature sensor is located in the reservoir assembly. However, the temperature sensor could also be located external to the reservoir assembly, and in such an embodiment it could be integrated into the manifold.
具有通过使用可以集成到歧管中的温度传感的三个主要方法。本领域技术人员将要理解的是，每个方法的变化形式是可能的，而不导致歧管总体设计的任何显著变化。这些方法讨论如下：There are three main methods by which temperature sensing can be integrated into the manifold by use. Those skilled in the art will appreciate that variations of each method are possible without resulting in any significant changes to the overall design of the manifold. These methods are discussed below:
高传导性流体接触High Conductivity Fluid Contact
在高传导性直接流体接触方法中，金属盘被内置到歧管的壁中，其中热敏电阻器或本领域中已知的任何其他合适的温度传感器被放置为在透析机侧上与金属盘接触并且在患者侧上与流体接触。流体温度可以因此通过金属盘得到监视。In the high conductivity direct fluid contact method, a metal disc is built into the wall of the manifold with a thermistor or any other suitable temperature sensor known in the art placed in contact with the metal disc on the side of the dialysis machine. Contact and come into contact with fluid on the patient side. The fluid temperature can thus be monitored through the metal disc.
通常，温度通过将热敏电阻器直接地放置在流体流中被监视。在本发明中使用金属盘来监视温度提供降低污染风险的优点，并且因此避免需要清洁热敏电阻器。Typically, temperature is monitored by placing a thermistor directly in the fluid flow. Using a metal disc to monitor temperature in the present invention offers the advantage of reducing the risk of contamination and thus avoiding the need to clean the thermistor.
本领域技术人员要理解的是，任何合适金属例如316型不锈钢的金属盘都可以用于该目的。此外，可以采用适用于目前应用的任何热敏电阻器。示例性热敏电阻器是由BetaTherm制造的零件编号10K3AlA。It will be appreciated by those skilled in the art that a metal disc of any suitable metal, such as Type 316 stainless steel, may be used for this purpose. Also, any thermistor suitable for the application at hand can be used. An exemplary thermistor is part number 10K3AlA manufactured by BetaTherm.
在一个实施方案中，金属盘是用于单一患者用途的并且是一次性的，且热敏电阻器是透析机的一部分并且被反复使用。In one embodiment, the metal disc is for single patient use and is disposable, and the thermistor is part of the dialysis machine and is used repeatedly.
中等传导性流体接触Moderate Conductivity Fluid Contact
紧凑歧管的压力换能器膜相对很薄，并且由中等热导率材料构建。通常使用0.040”的厚度并且可以从0.005”变化至0.050”。如果材料越薄且热导率越高，则压力换能器膜将越精确地将透析流体的温度传输至安装在透析机内的压力换能器。通过设计，它们与在机器侧上的压力换能器和在患者侧上的流体直接接触。将合适的温度传感器放置在压力换能器内允许流体温度的监视。本领域中已知的某些压力换能器包括用于根据温度漂移来校正换能器的温度传感器。这样的具有温度传感特征的压力换能器可以用于本申请的目的。示例性的组合压力—温度传感器是由MicronInstruments制造的型号MPT40。采用传感器的这种组合避免直接接触被测量的流体并且减少歧管中的部件数量。这提供了金属盘的替代形式，如在上文的方法中使用。The pressure transducer membrane of the compact manifold is relatively thin and constructed of a medium thermal conductivity material. A thickness of 0.040" is typically used and can vary from 0.005" to 0.050". The thinner the material and the higher the thermal conductivity, the more accurately the pressure transducer membrane will transmit the temperature of the dialysis fluid to the dialysis fluid installed in the dialysis machine. Pressure transducers. By design, they are in direct contact with the pressure transducers on the machine side and the fluid on the patient side. Placing suitable temperature sensors within the pressure transducers allows monitoring of fluid temperature. In the art Some known pressure transducers include a temperature sensor for correcting the transducer according to temperature drift. Such pressure transducers with temperature sensing features can be used for the purposes of this application. Exemplary combination pressure— The temperature sensor was a model MPT40 manufactured by Micron Instruments. Employing this combination of sensors avoids direct contact with the fluid being measured and reduces the number of parts in the manifold. This provides an alternative to the metal disk as used in the method above.
间接光学温度测量Indirect Optical Temperature Measurement
如果歧管流体路径的塑料壁具有有限的厚度，例如约0.020”，则塑料壁将在温度上与歧管内的流体平衡。在这样的条件下，非接触光学温度测量可以从变薄的壁的外侧进行，并且可以确定其内的流体温度。示例性的非接触光学温度传感器是由Melexis制造的零件编号MLX90614。非接触方法提供的优点是，其不需要歧管中的额外零件。唯一的要求是流体路径壁中的薄片段。该方法提供低成本，并且仍维持单一患者使用安全特征。If the plastic wall of the manifold fluid path has a finite thickness, such as about 0.020", the plastic wall will be in temperature equilibrium with the fluid within the manifold. Under such conditions, non-contact optical temperature measurement can be obtained from the thickness of the thinned wall. outside, and the temperature of the fluid within it can be determined. An exemplary non-contact optical temperature sensor is part number MLX90614 manufactured by Melexis. The non-contact method offers the advantage that it does not require additional parts in the manifold. The only requirement is a thin segment in the fluid path wall. This approach provides low cost and still maintains a single patient use safety feature.
一个可能的用于歧管中的集成电导传感器的实施方式是作为具有接触透析液流体的电引脚的电导电池。示例性电导电池的技术细节在图57中示出。参照图57，电导电池5700包括用于将小恒定电流施加至流体的偏置引脚570l。传感引脚5702探测流体中的电压，其中探测到的电压的幅度取决于流体的电导和温度。通过使用放置为紧邻于电导电池5700的热敏电阻器5703来测量温度。可选地，可以通过上文所公开的手段之一来确定温度。因为已知在传感引脚5702的所测量的温度及电压的值，所以可以确定流体的电导。One possible implementation of the integrated conductivity sensor used in the manifold is as a conductivity cell with an electrical pin contacting the dialysate fluid. Technical details of an exemplary conductance cell are shown in FIG. 57 . Referring to Figure 57, a conductivity cell 5700 includes a bias pin 5701 for applying a small constant current to the fluid. Sense pin 5702 detects a voltage in the fluid, where the magnitude of the detected voltage depends on the conductance and temperature of the fluid. The temperature is measured by using a thermistor 5703 placed next to the conductivity cell 5700 . Alternatively, the temperature may be determined by one of the means disclosed above. Since the measured temperature and voltage values at sense pin 5702 are known, the conductance of the fluid can be determined.
通过偏置引脚570l施加的电流可以是DC或AC信号，并且通常在50—l00kHz频率范围内。在一个实施方案中，所施加的电流的幅度在10mA的数量级。传感引脚5702通常在电导电池的制造期间按深度定位，通常至+/-0.00l英寸的深度，校准溶液在电池中。热敏电阻器5703具有0.5摄氏度的典型精确度。电导电池可以通过将传导性引脚(偏置引脚和传感引脚)驱动或模制就位到歧管主体中使得它们与透析液接触但不允许透析液从歧管泄漏出来而被内置到紧凑歧管的透析液流体路径中。The current applied through bias pin 5701 can be a DC or AC signal and is typically in the 50-100 kHz frequency range. In one embodiment, the magnitude of the applied current is on the order of 10 mA. The sense pins 5702 are typically positioned at depth during manufacture of the conductivity cell, typically to a depth of +/- 0.001 inches with the calibration solution in the cell. Thermistor 5703 has a typical accuracy of 0.5 degrees Celsius. Conductivity cells can be built in by driving or molding the conductivity pins (bias and sense) into the manifold body such that they are in contact with the dialysate but do not allow the dialysate to leak out of the manifold into the dialysate fluid path of the compact manifold.
断开探测Disconnect detection
所公开的透析系统的实施方案还结合用于探测在正被用于任何血液处理治疗程序的体外血液回路中的断开的设备和方法。血液处理治疗程序的示例包括血液透析、血液滤过、超滤或血浆分离置换。用于建立体外血液回路的血管通路通常通过使用透皮针或鲁尔连接的导液管来获得。断开设备和方法使用由患者跳动的心脏所产生的压力脉冲作为至脉管系统的完整针或导液管连接的指示物。由患者心脏所产生的压力脉冲很小；在体外血液回路的静脉回流线中更是如此。为了探测小压力脉冲，本发明使用交叉相关方法，其中基准心脏信号与压力脉冲信号交叉相关。Embodiments of the disclosed dialysis systems also incorporate apparatus and methods for detecting disconnections in an extracorporeal blood circuit being used for any blood treatment procedure. Examples of blood treatment procedures include hemodialysis, hemofiltration, ultrafiltration, or apheresis. Vascular access for establishing an extracorporeal blood circuit is usually obtained through the use of transdermal needles or luer-connected catheters. The disconnection devices and methods use the pressure pulse generated by the patient's beating heart as an indicator of a complete needle or catheter connection to the vasculature. The pressure pulses generated by the patient's heart are small; especially in the venous return line of the extracorporeal blood circuit. To detect small pressure pulses, the present invention uses a cross-correlation method in which a reference cardiac signal is cross-correlated with the pressure pulse signal.
图58是根据本发明实施方案的用于探测患者与体外血液回路断开的系统5800的框图。系统5800包括进入的动脉血液回路5802、透析器5804、透析液回路5806、患者脉搏压力换能器5808、用于基准的患者心脏信号发生器5815、断开监视器5820、控制器5825和返回静脉血液回路5810。在本发明的各种实施方案中，从患者抽吸的血液经由动脉血液回路5802穿过透析器5804，并且来自透析器5804的已被清洁的血液经由静脉血液回路5810返回至患者。从透析器5804排出的受污染的透析液在透析液回路5806内得到净化或再生，并且被泵送返回到透析器5804中。在本发明的各种实施方案中，已被清洁的血液经由透皮针或鲁尔连接的导液管返回至患者身体。返回静脉血液回路5810中的血液流量通常在300—400ml/min的范围内。应当理解的是，可以采用任何合适的透析回路。58 is a block diagram of a system 5800 for detecting disconnection of a patient from an extracorporeal blood circuit in accordance with an embodiment of the present invention. System 5800 includes incoming arterial blood circuit 5802, dialyzer 5804, dialysate circuit 5806, patient pulse pressure transducer 5808, patient heart signal generator for reference 5815, disconnect monitor 5820, controller 5825, and return vein blood circuit 5810. In various embodiments of the invention, blood drawn from the patient passes through the dialyzer 5804 via the arterial blood circuit 5802 , and cleaned blood from the dialyzer 5804 is returned to the patient via the venous blood circuit 5810 . Contaminated dialysate drained from dialyzer 5804 is purified or regenerated within dialysate circuit 5806 and pumped back into dialyzer 5804 . In various embodiments of the invention, the cleaned blood is returned to the patient's body via a transdermal needle or luer-connected catheter. Blood flow in the return venous blood circuit 5810 is typically in the range of 300-400 ml/min. It should be understood that any suitable dialysis circuit may be used.
压力换能器5808测量经受血液处理治疗程序的患者的压力脉冲，并且将脉搏压力大致连续地通信至断开监视器5820。在一个实施方案中，换能器5808是定位在透析血液管线(进入的动脉血液回路5802或返回静脉血液回路5810)中的任何位置的侵入性的或非侵入性的静脉压力传感器。在另一个实施方案中，换能器5808是特别定位在透析器5804和患者之间的透析血液管线中(即在返回静脉血液回路5810中)的侵入性的或非侵入性的静脉压力传感器。非侵入性的空气泡探测器和/或夹管阀(未示出)可选地定位在换能器5808和至患者的鲁尔连接部之间。在本发明的一个实施方案中，压力换能器5808定位成紧邻于插入患者身体中的用于提供对应于返回静脉血液回路5810的血管通路的针或导液管。压力换能器5808定位成紧邻于针或导液管，以便维持波形保真度。在其他实施方案中，压力换能器5808可以连接在返回静脉血液回路5810中的任何位置。在本发明的一个实施方案中，由压力换能器5808产生的压力信号是交流(AC)信号，其不是血管压力的精确测量。因此，压力换能器5808不是高精确度换能器。Pressure transducer 5808 measures pressure pulses of a patient undergoing a blood treatment procedure and communicates the pulse pressure substantially continuously to disconnect monitor 5820 . In one embodiment, the transducer 5808 is an invasive or non-invasive venous pressure sensor positioned anywhere in the dialysis blood line (incoming arterial blood circuit 5802 or return venous blood circuit 5810). In another embodiment, the transducer 5808 is an invasive or non-invasive venous pressure sensor positioned specifically in the dialysis blood line between the dialyzer 5804 and the patient (ie, in the return venous blood circuit 5810). A non-invasive air bubble detector and/or pinch valve (not shown) is optionally positioned between the transducer 5808 and the luer connection to the patient. In one embodiment of the invention, pressure transducer 5808 is positioned in close proximity to a needle or catheter inserted into the patient's body for providing vascular access corresponding to return venous blood circuit 5810 . The pressure transducer 5808 is positioned in close proximity to the needle or catheter in order to maintain waveform fidelity. In other embodiments, the pressure transducer 5808 may be connected anywhere in the return venous blood circuit 5810 . In one embodiment of the invention, the pressure signal generated by pressure transducer 5808 is an alternating current (AC) signal, which is not an accurate measurement of blood vessel pressure. Therefore, pressure transducer 5808 is not a high precision transducer.
基准信号发生器5815将患者的心脏信号大致连续地通信至断开监视器5820用于参考。在本发明的一个实施方案中，基准心脏信号从连接到将处理过的血液供应至患者的针或导液管所连接到的相同身体部分(例如臂)的体积描记器获得。在本发明的另一个实施方案中，基准心脏信号从手指脉搏传感器/血氧计获得。在本发明的各种其他实施方案中，基准心脏信号可以通过心电图(ECG)信号、实时血液压力信号、听诊器、来自血液抽出管线的动脉压力信号、血氧计脉冲信号、可变部位体积描记器信号、透射性和/或反射性体积描记器信号、声学心脏信号、腕脉搏获得或者从任何其他的本领域技术人员已知的心脏信号源获得。Reference signal generator 5815 communicates the patient's cardiac signal substantially continuously to disconnection monitor 5820 for reference. In one embodiment of the invention, the reference cardiac signal is obtained from a plethysmograph connected to the same body part (eg arm) to which the needle or catheter supplying the treated blood to the patient is connected. In another embodiment of the invention, the reference cardiac signal is obtained from a finger pulse sensor/oximeter. In various other embodiments of the invention, the reference cardiac signal can be obtained by an electrocardiogram (ECG) signal, a real-time blood pressure signal, a stethoscope, an arterial pressure signal from a blood draw line, an oximeter pulse signal, a variable site plethysmograph signal, transmissive and/or reflective plethysmograph signal, acoustic cardiac signal, wrist pulse acquisition or from any other source of cardiac signal known to those skilled in the art.
断开监视器5820探测返回静脉血液回路5810中被针或导液管与经受血液处理治疗的患者身体的断开所导致的中断。为了探测断开，监视器5820处理患者脉搏压力换能器信号和心脏基准信号。本领域技术人员要理解的是，这样的断开可以由针或导液管因任何原因例如患者的突然运动被从患者身体拉出所导致。参照图59对断开监视器5808进行详细描述。控制器5825是本领域技术人员已知的任何微处理器。控制器5825的功能是接收来自监视器5820的处理过的输入且因此在需要时触发合适的动作。Disconnection monitor 5820 detects interruptions in return venous blood circuit 5810 caused by disconnection of a needle or catheter from the body of the patient undergoing blood processing treatment. To detect disconnection, the monitor 5820 processes the patient pulse pressure transducer signal and the cardiac reference signal. Those skilled in the art will appreciate that such disconnection may be caused by the needle or catheter being pulled out of the patient's body for any reason, such as sudden movement of the patient. The disconnection monitor 5808 is described in detail with reference to FIG. 59 . Controller 5825 is any microprocessor known to those skilled in the art. The function of the controller 5825 is to receive processed input from the monitor 5820 and thus trigger appropriate actions when required.
本领域技术人员应当理解的是，压力换能器和基准信号通过结合到基准信号发生器和压力换能器中的发射器而通信至断开监视器5820。发射器可以使得能够有线或无线地通信至相应的接收器。类似地，来自断开监视器5820的数据通过有线或无线连接部通信至控制器5825。在一个实施方案中，通过使用合适的有线或无线公共和/或私人网络例如LAN、WAN、MAN、蓝牙网络和/或国际互联网能够得到这种信号通信。此外，在一个实施方案中，断开监视器5820和控制器5825定位成彼此紧邻且紧邻于压力换能器5808和心脏基准信号发生器5815。在一个可选择的实施方案中，断开监视器5820和控制器5825中的一个或两个定位在距彼此和/或距系统5800的其余部件远距离处。Those skilled in the art will appreciate that the pressure transducer and reference signal are communicated to the disconnect monitor 5820 through transmitters incorporated into the reference signal generator and pressure transducer. A transmitter may enable wired or wireless communication to a corresponding receiver. Similarly, data from disconnect monitor 5820 is communicated to controller 5825 via a wired or wireless connection. In one embodiment, such signal communication can be obtained through the use of suitable wired or wireless public and/or private networks such as LAN, WAN, MAN, Bluetooth networks and/or the Internet. Furthermore, in one embodiment, the disconnection monitor 5820 and the controller 5825 are positioned in close proximity to each other and to the pressure transducer 5808 and the cardiac reference signal generator 5815 . In an alternative embodiment, one or both of the disconnect monitor 5820 and the controller 5825 are located at a remote distance from each other and/or from the rest of the system 5800.
图59是根据本发明一个实施方案的用于探测返回静脉血液回路中的断开的设备5900的框图图示。断开监视器5900包括压力换能器接收器5902、基准信号接收器5904和交叉相关处理器5906。换能器接收器5902和基准信号接收器5904接收分别来自图58的压力换能器5808和心脏基准信号发生器5815的输入信号。Figure 59 is a block diagram illustration of an apparatus 5900 for detecting a break in a return venous blood circuit, according to one embodiment of the invention. Disconnect monitor 5900 includes pressure transducer receiver 5902 , reference signal receiver 5904 and cross-correlation processor 5906 . Transducer receiver 5902 and reference signal receiver 5904 receive input signals from pressure transducer 5808 and cardiac reference signal generator 5815 of FIG. 58, respectively.
由压力换能器接收器5902获得的压力脉冲信号和由基准信号接收器5904获得的基准心脏信号存储在本地存储器中并且还被供给至交叉相关处理器5906，该交叉相关处理器进而计算两个信号之间的相关性。处理器5906的输出被供给到图58的控制器5825中。如果由交叉相关处理器5906产生的输出指示两个输入信号之间的相关性，则推断出返回静脉血液回路是完整的。如果由交叉相关处理器5906产生的输出不指示两个输入信号之间的相关性，则推断出返回静脉血液回路由于针或导液管拉出而被中断，且图58的控制器5825触发合适当的动作，例如发出指示性的警报和/或完全地或部分地关闭透析系统。The pressure pulse signal obtained by the pressure transducer receiver 5902 and the reference cardiac signal obtained by the reference signal receiver 5904 are stored in local memory and also fed to the cross-correlation processor 5906 which in turn calculates two Correlation between signals. The output of the processor 5906 is fed into the controller 5825 of FIG. 58 . If the output produced by the cross-correlation processor 5906 indicates a correlation between the two input signals, it is concluded that the return venous blood circuit is intact. If the output produced by the cross-correlation processor 5906 does not indicate a correlation between the two input signals, it is concluded that the return venous blood circuit has been interrupted due to needle or catheter pullout, and the controller 5825 of FIG. 58 triggers the appropriate appropriate actions, such as issuing an indicative alarm and/or shutting down the dialysis system completely or partially.
本领域技术人员应当注意的是，本发明设想使用联系、相应或以其他方式产生在压力换能器信号和基准信号之间的可测量的、可量化的和/或可预测的关系的任何交叉相关处理器。在本发明的一个实施方案中，交叉相关通过使用锁定放大器来进行，例如由加利福尼亚州的StanfordResearchSystems制造的SR810锁定放大器。用于非常低信噪比系统和心脏信号的交叉相关探测的各种已知技术可以结合在交叉相关处理器5906中。It should be noted by those skilled in the art that the present invention contemplates any crossover using relational, corresponding, or otherwise producing a measurable, quantifiable, and/or predictable relationship between the pressure transducer signal and the reference signal. associated processor. In one embodiment of the invention, cross-correlation is performed using a lock-in amplifier, such as the SR810 lock-in amplifier manufactured by Stanford Research Systems of California. Various known techniques for cross-correlation detection of very low signal-to-noise ratio systems and cardiac signals may be incorporated in the cross-correlation processor 5906.
在本发明的各种实施方案中，由交叉相关处理器5906计算的交叉相关函数用于测量两个输入信号即基准心脏信号和压力脉冲信号之间的相似度。交叉相关函数的计算包括在指定时间框架或窗口内两个输入信号的相应成对点的乘积的和的计算。计算还通过包括首项或后项将两个输入信号之间的任何潜在的相位差考虑在内。对应于交叉相关函数的数学公式表示为：In various embodiments of the invention, the cross-correlation function computed by the cross-correlation processor 5906 is used to measure the similarity between two input signals, the reference heart signal and the pressure pulse signal. The calculation of the cross-correlation function involves the calculation of the sum of the products of corresponding pairs of points of two input signals within a specified time frame or window. The calculation also takes into account any potential phase difference between the two input signals by including a leading or trailing term. The mathematical formula corresponding to the cross-correlation function is expressed as:
其中N代表样本的数量，j代表滞后系数，xl和x2分别代表两个输入信号。Among them, N represents the number of samples, j represents the lag coefficient, and xl and x2 represent two input signals respectively.
图60是示出了根据本发明一个实施方案的确定患者与体外血液回路断开的方法的示例性步骤的流程图。在操作中，包括多个指令并且在处理器上执行的透析系统软件提示患者首先附接心脏信号发生器(例如手指脉搏血氧计)来获得6005基准信号。在该点，患者可以或可以不连接到透析系统。在捕获心脏基准信号的之后或同时，包括多个指令并且在处理器上执行的透析系统软件提示患者连接到图58的系统5800，由此患者脉搏压力换能器信号也被获得6010。然后，交叉相关处理器试图相关6015基准信号和换能器信号。如果没有相关性可以在启动时被实现，那么在一个实施方案中，提示患者关闭6020所有或某些部件，或者在另一个实施方案中，图58的系统5800的控制器5825自动地进行这些操作来降低噪声水平。例如，关闭透析系统的泵可以降低噪声，并且使得更容易捕获和相关这两个信号。在另一个实施方案中，在产生噪声的系统部件例如泵被开启之前尝试交叉相关。因此，在完全的系统启动可被完成之前尝试锁定相关性。在一个实施方案中，如果没有相关性被锁定，则警报被触发，指示患者透析系统可能具有异常。FIG. 60 is a flowchart illustrating exemplary steps of a method of determining that a patient is disconnected from an extracorporeal blood circuit according to one embodiment of the present invention. In operation, dialysis system software comprising a number of instructions and executing on a processor prompts the patient to first attach a cardiac signal generator (eg, finger pulse oximeter) to obtain 6005 a reference signal. At this point, the patient may or may not be connected to the dialysis system. After or concurrently with capturing the cardiac reference signal, the dialysis system software comprising a plurality of instructions and executing on the processor prompts the patient to connect to the system 5800 of FIG. 58 whereby a patient pulse pressure transducer signal is also obtained 6010 . The cross-correlation processor then attempts to correlate 6015 the reference signal and the transducer signal. If no correlation can be achieved at startup, then in one embodiment the patient is prompted to turn off 6020 all or certain components, or in another embodiment the controller 5825 of the system 5800 of FIG. 58 does so automatically to reduce the noise level. For example, turning off the pump of the dialysis system reduces the noise and makes it easier to capture and correlate the two signals. In another embodiment, the cross-correlation is attempted before a noisy system component such as a pump is turned on. Therefore, an attempt is made to lock dependencies before a full system boot can be completed. In one embodiment, if no correlation is locked, an alarm is triggered indicating that the patient's dialysis system may have an anomaly.
然而，如果获得了相关性，则该相关性被大致持续地监视6025。如果具有在该相关性中的任何偏离，则警报被触发6030，指示可能的泄漏，或者可选的是系统被关闭(完全地或部分地)并且为了尝试再建立相关的信号被再次尝试。在一个实施方案中，如果相关性的本质改变或偏离超出预定阈值或在预定义的阈值内，则某些系统部件例如泵被关闭且交叉相关处理器尝试再建立相关性。如果相关性不能被再建立，则警报被触发。在另一个实施方案中，如果相关性的本质改变或偏离超出预定阈值的范围或者在预定阈值的范围之外，则某些系统部件例如泵被关闭，并且在再建立相关性的任何另外尝试之前，警报被立即触发。However, if a correlation is obtained, it is monitored 6025 substantially continuously. If there is any deviation in the correlation, an alarm is triggered 6030, indicating a possible leak, or alternatively the system is shut down (completely or partially) and the signal is tried again in order to attempt to re-establish the correlation. In one embodiment, if the nature of the correlation changes or deviates beyond or within predefined thresholds, certain system components, such as pumps, are shut down and the cross-correlation processor attempts to re-establish the correlation. If the correlation cannot be re-established, an alarm is triggered. In another embodiment, if the nature of the correlation changes or deviates beyond or outside a range of predetermined thresholds, certain system components, such as pumps, are shut down and prior to any further attempts to establish the correlation , the alert is triggered immediately.
这种用于监视断开的方法提供相对于现有技术的某些明显的改进。首先，不同于现有技术，本发明响应的是针仅被略微地拉出或者其被从插入部位移除且拉动非常多的距离。第二，本发明不需要任何额外的设备放置在插入部位，例如防潮垫。第三，通过交叉相关患者自己的心脏信号，假阴性被大大消除。第四，压力脉冲传感和交叉相关的组合使本发明是独特的并且能够探测低信噪比信号。第五，连续地监视交叉相关状态使系统能够探测可能潜在地指示断开的小信号偏离。因此，用于探测正被用于任何血液处理治疗程序的体外血液回路中的断开的设备和方法由本发明提供。This method for monitoring disconnection offers some significant improvements over the prior art. Firstly, unlike the prior art, the present invention responds to the needle being pulled out only slightly or it being removed from the insertion site and pulled a very large distance. Second, the present invention does not require any additional equipment to be placed at the insertion site, such as moisture-proof pads. Third, by cross-correlating the patient's own cardiac signal, false negatives are largely eliminated. Fourth, the combination of pressure pulse sensing and cross-correlation makes the present invention unique and capable of detecting low signal-to-noise ratio signals. Fifth, continuously monitoring cross-correlation status enables the system to detect small signal deviations that could potentially indicate a disconnect. Accordingly, an apparatus and method for detecting a break in an extracorporeal blood circuit being used for any blood treatment procedure is provided by the present invention.
中心静脉压监视central venous pressure monitoring
本文公开的透析系统的实施方案还结合用于监视和控制超滤(UF)速率使得经受透析/超滤的患者内的流体的体积保持在期望范围内的方法和系统。本发明将中心静脉压(CVP)监视集成到透析系统中并且使用CVP测量控制超滤(UF)的速率。CVP反馈数据有助于作为安全测量防止流体的过度移除，并且提供用于为了改进疗法的滴定UF速率的手段。Embodiments of the dialysis systems disclosed herein also incorporate methods and systems for monitoring and controlling ultrafiltration (UF) rates such that the volume of fluid within a patient undergoing dialysis/ultrafiltration remains within a desired range. The present invention integrates central venous pressure (CVP) monitoring into the dialysis system and uses the CVP measurement to control the rate of ultrafiltration (UF). CVP feedback data helps prevent over-removal of fluid as a safety measure and provides a means for titrating UF rates for improved therapy.
CVP测量要求测量在用于透析的中心静脉导管中存在的平均压力，从而将CVP测量与透析集成。为了测量CVP，合适的导液管需要插入患者身体中，使得导液管的端头放置在胸廓内。图6l描绘了用于血液滤过和CVP测量的中心静脉导管的示例性部位。参照图6l，中心静脉导管(CVC)6110用于提供用于UF的血管通路。在本特别实施方案中，被选择用于CVC6110的进入部位6120在锁骨(锁骨)6130下方，在锁骨下静脉6140处。本领域技术人员要理解的是，患者身体中的任何其他大静脉可以被选择作为用于插入CVC的可选部位，同时保持其端头在胸廓内。CVC6110穿过皮下通道6150，并且借助于夹持器6160和标准鲁尔锁定器6170而被固定。在出口部位6180的在CVC端头处的压力等于中心静脉压。CVP measurement requires measuring the mean pressure present in the central venous catheter used for dialysis, thus integrating CVP measurement with dialysis. In order to measure CVP, a suitable catheter needs to be inserted into the patient's body such that the tip of the catheter is placed within the thorax. Figure 61 depicts an exemplary site for a central venous catheter for hemofiltration and CVP measurement. Referring to Figure 61, a central venous catheter (CVC) 6110 is used to provide vascular access for UF. In this particular embodiment, the site of entry 6120 selected for the CVC 6110 is below the collarbone (clavicle) 6130 at the subclavian vein 6140 . It will be appreciated by those skilled in the art that any other large vein in the patient's body may be selected as an alternative site for insertion of the CVC while keeping its tip within the thorax. The CVC 6110 passes through the subcutaneous channel 6150 and is secured with the aid of a clamp 6160 and a standard luer lock 6170 . The pressure at the CVC tip at the outlet site 6180 is equal to the central venous pressure.
在本发明的一个实施方案中，CVC6110用于在血液滤过期间到达血液，并且中心静脉压可以通过使用在血液滤过机器内的传感器而被测量。在这种情况下，不需要另外的设备用于CVP测量。在另一个实施方案中，二管腔CVC用于血液滤过。在这种情况下，近端管腔可以用于血液抽出，远端管腔(在端头处)可以用于返回血液。管腔或端口可以提供CVP测量。在两种情况下，当CVC用于血液到达时，本发明的系统提供在进行CVP测量之前血液流动被暂时停止，以使得能够精确测量压力。因此，在一个实施方案中，本发明集成到常规的透析机程序控制中，用于基于预定的CVP测量速率来停止血液流过该装置。In one embodiment of the invention, a CVC 6110 is used to reach the blood during hemofiltration, and central venous pressure can be measured using a sensor within the hemofiltration machine. In this case, no additional equipment is required for CVP measurement. In another embodiment, a two-lumen CVC is used for hemofiltration. In this case, the proximal lumen can be used for blood withdrawal and the distal lumen (at the tip) can be used for returning blood. A lumen or port can provide CVP measurement. In both cases, when the CVC is used for blood arrival, the system of the present invention provides that the blood flow is temporarily stopped before the CVP measurement is taken to enable accurate measurement of pressure. Thus, in one embodiment, the present invention is integrated into a conventional dialysis machine program control for stopping blood flow through the device based on a predetermined CVP measurement rate.
图62是示出了本发明的透析控制系统的框图。参照图62，提供从用户(临床医师)接收指示CVP测量的优选频率和CVP值的优选范围的输入的用户界面6210。这些输入被提供至中央透析控制器6220。中央透析控制器6220是可以用于调节CVP监视并且基于被监视的CVP调节血液透析/超滤的速率的可编程系统。取决于由用户确定的CVP测量的频率，中央透析控制器6220在CVP测量待被记录时将信号通信至透析系统6230中的血液泵来停止血液流动。接着，透析系统6230中的CVP传感器进行测量并且将其通信至中央透析控制器6220，该控制器可以将其传输至用户界面6210用于显示。在CVP测量完成之后，中央透析控制器6220将另一个信号通信至透析系统6230，使血液流动恢复。中央透析控制器6220也保持追踪测量到的CVP值以确定它们是否在用户定义的范围内。CVP减小到低于限定的范围将指示血容量减少。在这样的情况下，中央透析控制器6220中止超滤的过程，使得没有另外的流体可以被除去，直到CVP恢复至期望的范围。在一个实施方案中，中央透析控制器6220将超滤液移除滴定至2-6mmHg的范围，这将CVP保持在期望的范围内。Fig. 62 is a block diagram showing the dialysis control system of the present invention. Referring to Figure 62, a user interface 6210 is provided that receives input from a user (clinician) indicating a preferred frequency of CVP measurements and a preferred range of CVP values. These inputs are provided to the central dialysis controller 6220. The central dialysis controller 6220 is a programmable system that can be used to adjust CVP monitoring and adjust the rate of hemodialysis/ultrafiltration based on the monitored CVP. Depending on the frequency of CVP measurements determined by the user, the central dialysis controller 6220 communicates a signal to the blood pumps in the dialysis system 6230 to stop blood flow when a CVP measurement is to be recorded. The CVP sensor in the dialysis system 6230 then takes the measurement and communicates it to the central dialysis controller 6220, which can transmit it to the user interface 6210 for display. After the CVP measurement is complete, the central dialysis controller 6220 communicates another signal to the dialysis system 6230, allowing blood flow to resume. The central dialysis controller 6220 also keeps track of the measured CVP values to determine if they are within user-defined ranges. A decrease in CVP below a defined range would indicate hypovolemia. In such cases, the central dialysis controller 6220 suspends the process of ultrafiltration so that no additional fluid can be removed until the CVP returns to the desired range. In one embodiment, the central dialysis controller 6220 titrates the ultrafiltrate removal to a range of 2-6 mmHg, which keeps the CVP within the desired range.
CVP监视和UF调节系统设想与常规透析机集成的宽范围CVP测量系统。测量CVP可以以多种方式实现。在一个实施方案中，CVP可以采用定位在合适导液管端头处的传感器来测量。在另一个实施方案中，CVP可以采用定位在距导液管远距离处的专用压力换能器来测量，其中换能器保持在与心脏相同的水平处。图63是后一个实施方案的示例性图示。参照图63，示出了用于到达血液的导液管6310。导液管6310放置在中央腔静脉6320中。压力换能器6330在心脏水平测量中央静脉压。在这种情况下，CVP测量用于以与在使用CVC时相同的方式控制血液滤过的速率。The CVP monitoring and UF regulation system envisages a wide range CVP measurement system integrated with conventional dialysis machines. Measuring CVP can be accomplished in a number of ways. In one embodiment, CVP can be measured using a sensor positioned at the tip of a suitable catheter. In another embodiment, CVP can be measured with a dedicated pressure transducer positioned remotely from the catheter, where the transducer is held at the same level as the heart. Figure 63 is an exemplary illustration of the latter embodiment. Referring to Figure 63, a catheter 6310 for accessing blood is shown. Catheter 6310 is placed in central vena cava 6320. Pressure transducer 6330 measures central venous pressure at the level of the heart. In this case, CVP measurement is used to control the rate of hemofiltration in the same way as when using CVC.
在另一个实施方案中，采用在血液滤过机器内的远程传感器来测量CVP。参照图64，示出了具有提供CVP测量的示例性血液回路6400。随着血液从患者进入回路6400，抗凝剂通过使用注射器640l被注射到血液中以防止凝结。提供了用于测量中央静脉压的压力传感器PBIP6410。血液泵6420将来自患者的血液推入透析器6430中。两个其他的压力传感器PBI6411和PBO6412分别设置在透析器6430的入口和出口。压力传感器PBI6411和PBO6412有助于保持追踪和保持在血液透析系统中的优势点处的流体压力。成对旁通阀B6413和A6414也随透析器设置，这确保流体流动在闭环透析回路中沿所期望的方向。用户可以在端口6417除去空气，如果空气泡已经被传感器6418探测到的话。血液温度传感器6416设置在空气消除端口6417之前。AIL/PAD传感器6418和夹管阀6419用在回路中，以确保清洁血液平稳且无阻碍地流向患者。帮助在系统用于透析之前准备系统的预充套件642l被预附接到血液透析系统。In another embodiment, CVP is measured using a remote sensor within the hemofiltration machine. Referring to Fig. 64, there is shown an exemplary blood circuit 6400 that provides CVP measurements. As blood enters circuit 6400 from the patient, anticoagulant is injected into the blood using syringe 6401 to prevent clotting. A pressure transducer PBIP6410 for measuring central venous pressure is provided. Blood pump 6420 pushes blood from the patient into dialyzer 6430. Two other pressure sensors PBI6411 and PBO6412 are placed at the inlet and outlet of the dialyzer 6430, respectively. Pressure transducers PBI6411 and PBO6412 help to keep track and maintain the fluid pressure at the vantage point in the hemodialysis system. A pair of bypass valves B6413 and A6414 are also provided with the dialyzer, which ensures fluid flow in the desired direction in the closed loop dialysis circuit. The user can remove air at port 6417 if air bubbles have been detected by sensor 6418. A blood temperature sensor 6416 is placed before the air removal port 6417. AIL/PAD sensor 6418 and pinch valve 6419 are used in the circuit to ensure a smooth and unimpeded flow of clean blood to the patient. A priming set 6421 is pre-attached to the hemodialysis system to help prepare the system before it is used for dialysis.
为了进行CVP测量，通过停止血液泵6420来停止回路6400中的血液流动。在这点，用于到达血液的导管(未示出)中的压力将平衡，并且在血液滤过机器中的压力传感器PBIP6410所测量的压力将等于在导管端头处的压力。该测量的压力(CVP)然后用于调节超滤的速率以及从患者移除的流体的体积。For CVP measurements, blood flow in circuit 6400 is stopped by stopping blood pump 6420 . At this point the pressures in the catheter (not shown) used to reach the blood will equalize and the pressure measured by the pressure sensor PBIP6410 in the hemofiltration machine will be equal to the pressure at the catheter tip. This measured pressure (CVP) is then used to regulate the rate of ultrafiltration and the volume of fluid removed from the patient.
因此可操作地，本发明的系统修改了常规的透析系统，使得超滤被以由医师预设的速率进行。周期性地，血液流动被停止并且通过使用上文描述的各种测量方法之一来测量平均CVP。在一个实施方案中，提供安全模式，其中如果CVP下降至低于预设极限，则血液滤过就被中断并且警报响起。Operatively, therefore, the system of the present invention modifies conventional dialysis systems such that ultrafiltration is performed at a rate preset by the physician. Periodically, blood flow is stopped and mean CVP is measured using one of the various measurement methods described above. In one embodiment, a safety mode is provided wherein if the CVP drops below a preset limit, hemofiltration is interrupted and an alarm is sounded.
在另一个应用中，高血容量患者，例如患有充血性心力衰竭(CHF)的患者可被给予超滤来移除流体。本领域中已知的是，虽然超滤过程从血液移除流体，但希望被移除的流体定位在组织间隙中。此外，流体从组织间隙流到血液中的速率是未知的。如果没有本发明的系统，则医师仅能够猜测将把从血流的流体移除与从组织间隙流回到血液中的流体平衡的组织液移除速率，并且设置透析机用于该速率。在这样的情况下，要求在医师一方的持续监视来确保流体移除速率不过度地或不足地水化患者。如果采用本发明的系统，则医师就可以预设他想要移除的流体的总量(通常由患者重量计算)，以及被允许的最小平均CVP。系统然后以自动保持期望CVP的最大速率移除流体。也就是说，本发明的系统自动地将流体移除速率与从组织间隙到血液中的流体流量平衡。In another application, hypervolemic patients, such as patients with congestive heart failure (CHF), may be administered ultrafiltration to remove fluid. It is known in the art that while the ultrafiltration process removes fluid from blood, it is desired that the removed fluid be localized in the interstitial space. Furthermore, the rate at which fluid flows from the interstitial space into the blood is unknown. Without the system of the present invention, a physician can only guess at the rate of interstitial fluid removal that will balance fluid removal from the bloodstream with fluid flow back into the blood from the interstitial space, and set the dialysis machine for that rate. In such cases, continuous monitoring on the part of the physician is required to ensure that the rate of fluid removal does not over- or under-hydrate the patient. Using the system of the present invention, the physician can preset the total amount of fluid he wants to remove (usually calculated from the patient's weight), as well as the minimum average CVP allowed. The system then removes fluid at the maximum rate that automatically maintains the desired CVP. That is, the system of the present invention automatically balances the fluid removal rate with the fluid flow from the interstitial space into the blood.
应当理解的是，正常的CVP水平在2至6mmHg之间。升高的CVP指示水分过多，而减小的CVP指示血容量减少。通过使用本发明，患者可以以高于正常的CVP例如7-8mmHg开始超滤过程，并且经过例如6小时治疗过程以3mmtHg的最终CVP目标结束过程。然而，如果在治疗过程的中途，CVP已经下降多于期望下降的50％，而被移除的流体仅已经达到对于移除的最终目标的50％，则系统可被改编程序以减少流体移除的目标或减少流体移除的速率。还可以基于更复杂的算法来进行其他动作。最终结果是，通过监视CVP的速率和实际值来避免血容量减少。应当理解的是，该方法还可以用于控制流体移除速率，不仅是在血液滤过期间，而且用于所有类型的肾脏替代疗法。It should be understood that normal CVP levels are between 2 and 6 mmHg. Elevated CVP indicates hyperhydration, while decreased CVP indicates hypovolemia. By using the present invention, a patient can start an ultrafiltration session with a higher than normal CVP, eg, 7-8 mmHg, and end the session with a final CVP target of 3 mmtHg, eg, over a 6 hour treatment session. However, if midway through the course of treatment, the CVP has dropped by more than 50% of the desired drop, while the fluid removed has only reached 50% of the final goal for removal, the system can be reprogrammed to reduce fluid removal target or reduce the rate of fluid removal. Other actions can also be performed based on more complex algorithms. The end result is that hypovolemia is avoided by monitoring the rate and actual value of CVP. It should be understood that this method can also be used to control the rate of fluid removal, not only during hemofiltration, but for all types of renal replacement therapy.
监视和保持体积精确度Monitor and maintain volumetric accuracy
本文公开的透析系统的实施方案还结合用于保持血液透析系统中的置换液和输出流体的体积精确度的方法和系统。在一个实施方案中，该方法涉及交换在置换液侧和在输出侧使用的泵，使得等量的流体在每个侧被泵送。本发明的泵交换系统提供用于在透析程序期间保持流体体积的精确手段，并且可以被低成本地实施，以用于可反复使用的以及一次性的装置。Embodiments of the dialysis systems disclosed herein also incorporate methods and systems for maintaining volumetric accuracy of replacement fluid and output fluid in a hemodialysis system. In one embodiment, the method involves swapping the pumps used on the replacement fluid side and on the output side so that an equal amount of fluid is pumped on each side. The pump exchange system of the present invention provides an accurate means for maintaining fluid volume during dialysis procedures and can be implemented at low cost for reusable as well as disposable devices.
图65示出了如在一个实施方案中采用的示例性泵交换回路。用于血液滤过的泵交换回路6500包括两个泵，泵A6545和泵B6555。这两个泵与置换液回路R6560和输出流体回路O6570流体连通。通过两对二通阀6505和6507来促进流体连通。对于置换液回路R6560来说，置换液源6510通过限流器6517向该对二通阀6505提供流体。然后，取决于该对6505中的两个阀中的哪个是开放的，置换液被泵A6545或泵B6555泵送至第二组二通阀6507。该组二通阀6507将置换液引导至置换回路R6560，其与透析器6540的输出6542流体连通。在本实施方案中，与透析器6540的输出6542连通是后透析器输注配置。在本领域中已知的另一个配置中，代替地是与透析器的输入6544连通。本领域技术人员要理解的是，可以使用任一个配置，而不会影响本发明的范围。Figure 65 shows an exemplary pump exchange circuit as employed in one embodiment. The pump exchange circuit 6500 for hemofiltration includes two pumps, pump A 6545 and pump B 6555. These two pumps are in fluid communication with the replacement fluid circuit R6560 and the output fluid circuit O6570. Fluid communication is facilitated by two pairs of 2-way valves 6505 and 6507. For the replacement fluid circuit R6560, the replacement fluid source 6510 provides fluid to the pair of two-way valves 6505 through a restrictor 6517. Then, depending on which of the two valves in the pair 6505 is open, the replacement fluid is pumped by pump A 6545 or pump B 6555 to the second set of 2-way valves 6507 . The set of 2-way valves 6507 directs the replacement fluid to the replacement circuit R6560, which is in fluid communication with the output 6542 of the dialyzer 6540. In this embodiment, in communication with the output 6542 of the dialyzer 6540 is a post-dialyzer infusion configuration. In another configuration known in the art, the input 6544 is in communication with the dialyzer instead. It will be appreciated by those skilled in the art that either configuration may be used without affecting the scope of the present invention.
该对二通阀6505可以配置成可选地打开，使得可建立任何以下流体连通路径：The pair of two-way valves 6505 can be configured to be selectively opened such that any of the following fluid communication paths can be established:
●在输出流体回路O6570和泵A6545之间；● Between output fluid circuit O6570 and pump A6545;
●在置换液回路R6560和泵B6555之间；● Between the replacement fluid circuit R6560 and the pump B6555;
●在置换液回路R6560和泵A6545之间；以及，● between the replacement fluid circuit R6560 and the pump A6545; and,
●在输出流体回路O6570和泵B6555之间。• Between output fluid circuit O6570 and pump B6555.
系统6500还包括两个压力传感器6515和6516。传感器6516定位在输出回路O6570上，而传感器6515定位成紧邻于置换液源6510。压力传感器6515和6516用于监视压力。来自这些传感器的压力数据经由差分放大器6525被提供给主动限流器65l7。取决于压力测量，限流器6517根据需要可变地限制置换液的流动。System 6500 also includes two pressure sensors 6515 and 6516. Sensor 6516 is positioned on output loop O 6570 , while sensor 6515 is positioned in close proximity to replacement fluid source 6510 . Pressure sensors 6515 and 6516 are used to monitor pressure. Pressure data from these sensors is provided to active restrictor 6517 via differential amplifier 6525. Depending on pressure measurements, flow restrictor 6517 variably restricts the flow of replacement fluid as needed.
在透析期间，另外的流体可从患者以超滤液(UF)的形式移除，如果需要的话。为了本目的，提供了UF泵6535，其将UF泵送至袋或排放部6530。因为UF流体在输出流体子回路O6570中的压力测量的点之前被移除，所以体积精确度得到保持，与UF被移除的体积多少无关。During dialysis, additional fluid may be removed from the patient in the form of ultrafiltrate (UF), if desired. For this purpose, a UF pump 6535 is provided which pumps UF to the bag or drain 6530. Because UF fluid is removed prior to the point of pressure measurement in the output fluid subcircuit 06570, volumetric accuracy is maintained regardless of how much UF volume is removed.
操作性地，通过交换在置换液侧上和在输出侧上使用的泵6545和6555，使得在偶数次交换之后在每个点处泵送相同量的流体，从而实现本发明血液透析系统中的体积精确度。两对二通阀6505和6507帮助每个泵可选地与置换液回路R6560和输出流体回路O6570共同使用。Operationally, the hemodialysis system of the present invention is achieved by exchanging the pumps 6545 and 6555 used on the replacement fluid side and on the delivery side so that the same amount of fluid is pumped at each point after an even number of exchanges. volumetric accuracy. Two pairs of 2-way valves 6505 and 6507 facilitate the optional use of each pump with the replacement fluid circuit R6560 and output fluid circuit O6570.
在一个实施方案中，所使用的泵是蠕动泵。本领域技术人员要理解的是，还可以使用其他类型的泵，因为肾脏透析中的体积平衡通过使用泵交换技术来实现，并且不取决于泵的类型。在一个实施方案中，泵A6545比泵B6555递送每单位时间更多的流体。因此，这将导致在任何给定的时间段中比输出流体更多的置换液被泵送。In one embodiment, the pump used is a peristaltic pump. It will be appreciated by those skilled in the art that other types of pumps can also be used, since volume balance in kidney dialysis is achieved using pump exchange techniques and does not depend on the type of pump. In one embodiment, pump A6545 delivers more fluid per unit time than pump B6555. Therefore, this will result in more replacement fluid being pumped than output fluid in any given period of time.
本领域技术人员要理解的是，包括一次性元件的泵可以具有泵速率差，因为整个一次性元件的体积并不相等，即使它们具有相同的尺寸和类型。例如，插入两个注射器-泵组件内的两个具有标称相同尺寸的一次性注射器的容积将并不完全相同。本领域技术人员还要理解的是，不具有一次性元件的两个泵可以通常被调节，所以在二者之间将不具有泵送速率上的差别。通过使用可以采用本发明而被实施的一次性元件的泵的示例包括但不限于旋转或线性蠕动泵、注射器泵、转动叶片泵、离心泵和膜片泵。It will be understood by those skilled in the art that pumps including disposables may have differential pump rates because volumes are not equal throughout the disposables even though they are the same size and type. For example, two nominally the same size disposable syringes inserted into two syringe-pump assemblies will not have exactly the same volume. It will also be understood by those skilled in the art that two pumps without disposable elements can generally be adjusted so there will be no difference in pumping rate between the two. Examples of pumps using disposable elements that may be implemented employing the present invention include, but are not limited to, rotary or linear peristaltic pumps, syringe pumps, rotary vane pumps, centrifugal pumps, and diaphragm pumps.
为了实现置换液和输出流体之间的体积平衡，泵6545和6555每T分钟就被交换。在第一个‘T’分钟间隔的结束时，由于泵的特定特征，泵A6545将递送比泵B6555更多的体积。被泵A6545递送的流体体积被称为‘Q’。因此，如果在第一泵送间隔‘T’期间，置换液被引导通过泵A6545并且输出流体被引导通过泵B6555，那么在时间间隔T的结束时，置换液回路R6560相比于回路O6570中的输出流体，更多的‘Q’置换液将已被泵送。In order to achieve volumetric balance between replacement fluid and output fluid, pumps 6545 and 6555 are swapped every T minutes. At the end of the first 'T' minute interval, pump A6545 will deliver more volume than pump B6555 due to pump specific characteristics. The volume of fluid delivered by pump A6545 is referred to as 'Q'. Thus, if during the first pumping interval 'T', replacement fluid is directed through pump A 6545 and output fluid is directed through pump B 6555, then at the end of time interval T, the replacement fluid circuit R6560 is compared to that in circuit O6570 Output fluid, more 'Q' replacement fluid will have been pumped.
然后，泵A6545和B6555在下一个时间间隔中被交换，且回路O6570中的输出流体被泵A6545泵送和回路R6560中的置换液被泵B6555泵送。在该间隔中，相比于O6570中的输出流体，R6560中的更少的‘Q’置换液将被泵送。因此，在第二间隔的结束时(并且在偶数次交换的结束时)，在每个间隔期间被泵送的体积的差将是：Q-Q＝0。因此，在偶数次交换之后净体积差是零，从而实现被输注的置换液和从患者通过透析器返回的输出流体之间的体积平衡。本领域技术人员要理解的是，可以具有随时间推移的通过泵的流量的以及因此每单位时间被递送的体积的略微改变。在这种情况下，净体积差可以不精确地是零，而是非常接近于零。Then, pumps A6545 and B6555 are swapped in the next time interval, and output fluid in circuit O6570 is pumped by pump A6545 and replacement fluid in circuit R6560 is pumped by pump B6555. During this interval, less 'Q' replacement fluid in R6560 will be pumped compared to output fluid in O6570. Thus, at the end of the second interval (and at the end of the even number of exchanges), the difference in volume pumped during each interval will be: Q-Q=0. Thus, the net volume difference is zero after an even number of exchanges, thereby achieving a volume balance between the infused replacement fluid and the output fluid returning from the patient through the dialyzer. Those skilled in the art will appreciate that there may be slight variations in the flow rate through the pump over time and thus the volume delivered per unit time. In this case, the net volume difference may not be exactly zero, but very close to zero.
由蠕动泵泵送的体积取决于压头。用于泵的压头是子回路的功能而不是泵的功能，并且是在置换液回路R6560中相对于输出回路O6570在系统上不同。因此有必要均衡化由泵A6545和泵B6555所经历的压头。The volume pumped by a peristaltic pump depends on the head pressure. The head pressure for the pump is a function of the subcircuit rather than the pump, and is systematically different in the replacement fluid circuit R6560 relative to the output circuit O6570. It is therefore necessary to equalize the pressure head experienced by pump A 6545 and pump B 6555 .
在一个实施方案中，通过调制在从置换液源6510的输入回路上的限流器6517来均衡化压头。基于差分放大器6525的输出实现限流器调制，该差分放大器计算由位于泵6545和6555之间的压头传感器6515和6516测量的压力值之间的压力差。所需的补偿量将取决于泵如何受到置换液回路R6560和输出流体回路O6570中的压头影响。回路O6570中的压头将通常是负的。如果置换液袋(源)6510被升高至高于泵的水平的话，则回路R6560中的压头将是正的，如果袋竖直地定位成低于泵的水平的话，则回路R6560中的压头将是负的。对于利用重载泵管节段的泵来说，差可能相对较小。In one embodiment, the pressure head is equalized by modulating a flow restrictor 6517 on the input circuit from the replacement fluid source 6510. Restrictor modulation is achieved based on the output of a differential amplifier 6525 which calculates the pressure difference between the pressure values measured by head pressure sensors 6515 and 6516 located between pumps 6545 and 6555 . The amount of compensation required will depend on how the pump is affected by head pressure in the replacement fluid circuit R6560 and output fluid circuit O6570. The head pressure in loop 06570 will normally be negative. The head pressure in circuit R6560 will be positive if the replacement fluid bag (source) 6510 is raised above the level of the pump and if the bag is positioned vertically below the level of the pump will be negative. For pumps utilizing heavy duty pump tubing sections, the difference may be relatively small.
如所提到，通过测量子回路R6560和O6570中的压力，将这些压力作为输入提供至差分放大器6525，以及使用子回路R6560中被差分放大器6525的输出调节的可变限流器6517来调制来自置换液袋6510的流入量来均衡化压头。因为压头是子回路的功能而不是泵的功能，因此有必要调节在非调节状态中的两个子回路的压头之间的平均差。可以初始地以及在操作期间在期望的间隔通过简单地关闭调节来测量非调节状态下的压力。这种再校准无需停止泵送。As mentioned, by measuring the pressures in sub-loops R6560 and O6570, providing these pressures as input to differential amplifier 6525, and using variable current limiter 6517 in sub-loop R6560 regulated by the output of differential amplifier 6525 to modulate the output from Displacing the inflow of the fluid bag 6510 to equalize the pressure head. Since the head pressure is a function of the sub-circuits and not of the pump, it is necessary to regulate the average difference between the heads of the two sub-circuits in the unregulated state. The pressure in the unregulated state can be measured initially and at desired intervals during operation by simply turning off the regulation. This recalibration does not require pumping to be stopped.
在一个实施方案中，泵压头可以从零变化至超过几百mmHg，取决于所结合的透析器、置换液相对于透析机的高度以及透析液流量设置。例如，对于200ml/min的透析液流动以及悬挂在透析机上方5-10英寸的置换液袋来说，压力差在10mmHg的范围内。通常，当置换回路R6560中的压力比回路O6570中的压力更高时，限流器6517将限制来自置换液源6510的流动以便补偿该压力差。In one embodiment, the pump head can vary from zero to over several hundred mmHg, depending on the dialyzer incorporated, the height of the replacement fluid relative to the dialyzer, and the dialysate flow setting. For example, for a dialysate flow of 200 ml/min and a replacement fluid bag suspended 5-10 inches above the dialysis machine, the pressure differential is in the range of 10 mmHg. Typically, when the pressure in displacement circuit R6560 is higher than the pressure in circuit O6570, flow restrictor 6517 will restrict flow from displacement fluid source 6510 to compensate for the pressure difference.
对于使用其中透析液流体正被持续地再循环穿过吸附剂盒的闭环透析液回路的透析系统来说，图66示出了可选择的泵交换回路。用于血液滤过的泵交换回路6600包括两个泵，泵A6645和泵B6655。这两个泵与返回流体回路R6660和吸附剂流体回路S6670流体连通。流体连通借助于两对二通阀6605和6607得到促进。对于返回流体回路R6660来说，储液器流体源6610提供流体通过限流器6617至该对二通阀6605。然后，取决于该对6605中的两个阀中的哪个是开放的，置换液被泵A6645或泵g6655泵送至第二组二通阀6607。该组二通阀6607将流体通过吸附剂盒6608以及通过储液器6610引导至与透析器6640的输入端口6642流体连通的返回回路R6660。For dialysis systems using a closed loop dialysate circuit in which dialysate fluid is being continuously recirculated through the sorbent cartridge, Figure 66 shows an alternative pump swap circuit. The pump exchange circuit 6600 for hemofiltration includes two pumps, pump A 6645 and pump B 6655. These two pumps are in fluid communication with return fluid circuit R6660 and sorbent fluid circuit S6670. Fluid communication is facilitated by means of two pairs of 2-way valves 6605 and 6607. For return fluid circuit R6660, reservoir fluid source 6610 provides fluid through flow restrictor 6617 to the pair of two-way valves 6605. Then, depending on which of the two valves in the pair 6605 is open, the replacement fluid is pumped by pump A 6645 or pump g 6655 to the second set of 2-way valves 6607. The set of two-way valves 6607 directs fluid through the sorbent cartridge 6608 and through the reservoir 6610 to a return circuit R6660 in fluid communication with the input port 6642 of the dialyzer 6640 .
该对二通阀6605可以配置成可选地打开，使得可以建立任何以下流体连通路径：The pair of two-way valves 6605 can be configured to be selectively opened such that any of the following fluid communication paths can be established:
●在吸附剂流体回路S6670和泵A6645之间；● Between the sorbent fluid circuit S6670 and the pump A6645;
●在返回流体回路R6660和泵B6655之间；● Between return fluid circuit R6660 and pump B6655;
●在返回流体回路R6660和泵A6645之间；以及，● between return fluid circuit R6660 and pump A6645; and,
●在吸附剂流体回路S6670和泵B6655之间。• Between sorbent fluid circuit S6670 and pump B6655.
系统6600还包括两个压力传感器6615和6616。传感器6616定位在吸附剂回路S6670上，而传感器6615定位成紧邻于储液器流体源6610。压力传感器6615和6616用于监视压力。来自这些传感器的压力数据经由差分放大器6625而被提供至主动限流器6617。取决于压力测量，限流器6617根据需要可变地限制储液器流体的流动。System 6600 also includes two pressure sensors 6615 and 6616. Sensor 6616 is positioned on sorbent loop S6670, while sensor 6615 is positioned in close proximity to reservoir fluid source 6610. Pressure sensors 6615 and 6616 are used to monitor pressure. Pressure data from these sensors is provided to active restrictor 6617 via differential amplifier 6625. Depending on pressure measurements, flow restrictor 6617 variably restricts the flow of reservoir fluid as desired.
如在上文的实施方案中所述，本实施方案具有用于UF(超滤液)泵6635的设置，使得以(UF)形式的另外的流体可以在透析期间被从患者移除，如果需要的话。UF泵6635将超滤液泵送至袋或排放部6630。因为UF流体在吸附剂流体子回路S6670中的压力测量的点之前被移除，所以体积精确度得到保持，与UF被移除的体积多少无关。As described in the previous embodiments, this embodiment has a setup for a UF (ultrafiltrate) pump 6635 so that additional fluid in (UF) form can be removed from the patient during dialysis, if desired if. UF pump 6635 pumps the ultrafiltrate to bag or drain 6630. Because UF fluid is removed prior to the point of pressure measurement in the sorbent fluid subcircuit S6670, volumetric accuracy is maintained regardless of how much volume of UF is removed.
操作性地，通过交换在返回流体侧上和在吸附剂侧上使用的泵6645和6655，使得相同量的流体在偶数次交换之后在每个点处被泵送，从而实现本发明的血液透析系统中的体积精确度。两对二通阀6605和6607促进每个泵可选地与返回流体回路R6660和吸附剂流体回路S6670共同使用。Operationally, hemodialysis of the present invention is achieved by exchanging the pumps 6645 and 6655 used on the return fluid side and on the sorbent side such that the same amount of fluid is pumped at each point after an even number of exchanges Volumetric accuracy in the system. Two pairs of 2-way valves 6605 and 6607 facilitate the optional use of each pump with return fluid circuit R6660 and sorbent fluid circuit S6670.
在一个实施方案中，所使用的泵是蠕动泵。本领域技术人员要理解的是，还可以使用其他类型的泵，因为肾脏透析中的体积平衡通过使用泵交换技术来实现，并且不取决于泵的类型。在一个实施方案中，泵A6645比泵B6655递送每单位时间更多的流体。因此，这将导致在任何给定的时间段中比吸附剂流体更多的返回流体被泵送。In one embodiment, the pump used is a peristaltic pump. It will be appreciated by those skilled in the art that other types of pumps can also be used, since volume balance in kidney dialysis is achieved using pump exchange techniques and does not depend on the type of pump. In one embodiment, pump A6645 delivers more fluid per unit time than pump B6655. Consequently, this will result in more return fluid being pumped than adsorbent fluid in any given period of time.
本领域技术人员要理解的是，包括一次性元件的泵可以具有泵速率差，因为整个一次性元件的体积并不相等，即使它们具有相同的尺寸和类型。本领域技术人员还要理解的是，不具有一次性元件的两个泵可以通常被调节，所以在二者之间将不具有泵送速率上的差别。It will be understood by those skilled in the art that pumps including disposables may have differential pump rates because volumes are not equal throughout the disposables even though they are the same size and type. It will also be understood by those skilled in the art that two pumps without disposable elements can generally be adjusted so there will be no difference in pumping rate between the two.
为了实现返回流体和吸附剂流体之间的体积平衡，泵6645和6655每T分钟被交换。在第一个‘T’分钟间隔的结束时，由于泵的特定特征，泵A6645将递送比泵B6655更多的体积。被泵A6645递送的流体体积被称为‘Q’。因此如果在第一泵送间隔‘T’期间，储液器流体被引导通过泵A6645并且吸附剂流体被引导通过泵B6655，则在时间间隔T的结束时，相比于回路S6670中的吸附剂流体，在返回流体回路R6660中，更多的‘Q’储液器流体将已被泵送。然后，泵A6645和B6655在下一个时间间隔中被交换并且回路S6670中的吸附剂流体被泵A6645泵送，而回路R6660中的返回流体被泵B6655泵送。在该间隔中，相比于S6670中的吸附剂流体，R6660中更少的‘Q’储液器流体将被泵送。因此，在第二间隔的结束时(并且在偶数次交换的结束时)，在每个间隔期间被泵送的体积的差将是：Q-Q＝0。因此，在偶数次交换之后净体积差是零，从而实现被输注的返回流体和从患者通过透析器返回的吸附剂流体之间的体积平衡。此外，因为随时间推移可以具有通过泵的流量的某些通常的小变化，使得每单位时间被递送的体积改变，所以净体积差可以有时不精确地是零，而是大致接近于零。To achieve volumetric balance between return fluid and sorbent fluid, pumps 6645 and 6655 are swapped every T minutes. At the end of the first 'T' minute interval, pump A 6645 will deliver more volume than pump B 6655 due to pump specific characteristics. The volume of fluid delivered by pump A6645 is referred to as 'Q'. Thus if during the first pumping interval 'T', the reservoir fluid is directed through pump A 6645 and the sorbent fluid is directed through pump B 6655, at the end of time interval T, compared to the sorbent in circuit S6670 Fluid, in return fluid circuit R6660, more 'Q' reservoir fluid will have been pumped. Then, pumps A6645 and B6655 are swapped in the next time interval and the sorbent fluid in circuit S6670 is pumped by pump A6645 and the return fluid in circuit R6660 is pumped by pump B6655. During this interval, less 'Q' reservoir fluid will be pumped in the R6660 compared to the sorbent fluid in the S6670. Thus, at the end of the second interval (and at the end of the even number of exchanges), the difference in volume pumped during each interval will be: Q-Q=0. Thus, the net volume difference is zero after an even number of exchanges, thereby achieving a volume balance between infused return fluid and sorbent fluid returning from the patient through the dialyzer. Furthermore, because there may be some generally small change in flow through the pump over time, such that the volume delivered per unit time changes, the net volume difference may sometimes not be exactly zero, but roughly close to zero.
如对于在图65中示出的实施方案成立的那样，由图66所示的实施方案中的蠕动泵泵送的体积取决于压头。此外，因为用于泵的压头是子回路的功能而不是泵的功能，并且是在返回流体回路R6660中相对于吸附剂回路S6670在系统上不同，所以有必要均衡化由泵A6645和泵B6655经历的压头。As was true for the embodiment shown in Figure 65, the volume pumped by the peristaltic pump in the embodiment shown in Figure 66 depends on the head pressure. Furthermore, because the head pressure for the pump is a function of the subcircuit rather than the pump, and is systematically different in the return fluid circuit R6660 relative to the sorbent circuit S6670, it is necessary to equalize the pressure provided by pump A6645 and pump B6655 Head pressure experienced.
在一个实施方案中，通过调制在从储液器流体源6610的输入回路上的限流器6617来均衡化压头。限流器调制以与图65的实施方案相似的方式被实现，并且其基于差分放大器6625的输出。差分放大器6625计算位于泵6645和6655之间的压头传感器6615和6616所测量的压力值之间的压力差。所需的补偿量将取决于泵如何受到返回流体回路R6660和吸附剂流体回路S6670中的压头影响。回路S6670中的压头通常是负的。如果储液器6610被升高至高于泵的水平的话，则回路R6660中的压头将是正的，而如果储液器竖直地定位成低于泵的水平的话，则回路R6660中的压头将是负的。对于利用重载泵管节段的泵来说，该差可以相对较小。In one embodiment, the pressure head is equalized by modulating a flow restrictor 6617 on the input circuit from the reservoir fluid source 6610. Current limiter modulation is implemented in a similar manner to the embodiment of FIG. 65 and is based on the output of the differential amplifier 6625. Differential amplifier 6625 calculates the pressure difference between the pressure values measured by head pressure sensors 6615 and 6616 located between pumps 6645 and 6655 . The amount of compensation required will depend on how the pump is affected by the head pressure in the return fluid circuit R6660 and the sorbent fluid circuit S6670. The pressure head in circuit S6670 is normally negative. The head pressure in circuit R6660 will be positive if the reservoir 6610 is raised above the level of the pump, whereas the head pressure in circuit R6660 will be positive if the reservoir is positioned vertically below the level of the pump will be negative. This difference can be relatively small for pumps utilizing heavy duty pump tubing sections.
如所提到，通过测量子回路R6660和S6670中的压力，将这些压力作为输入提供给差分放大器6625，以及使用子回路R6660中的由差分放大器6625的输出所调节的可变限流器6617调制来自储液器6610的流入量来均衡化压头。因为压头是子回路的功能而不是泵的功能，因此要必要调节在非调节状态中的两个子回路的压头之间的平均差。在非调节状态中的压力可以被初始地测量并且在操作期间在期望的间隔通过简单地关闭调节而被测量。这种再校准无需停止泵送。As mentioned, by measuring the pressures in sub-loops R6660 and S6670, providing these pressures as input to differential amplifier 6625, and modulating Inflow from reservoir 6610 to equalize head pressure. Since the pressure head is a function of the subcircuits and not of the pump, it is necessary to adjust the average difference between the pressure heads of the two subcircuits in the unregulated state. The pressure in the unregulated state can be measured initially and at desired intervals during operation by simply turning off the regulation. This recalibration does not require pumping to be stopped.
在一个实施方案中，泵压头可以从零变化至超过几百mmHg，取决于所结合的透析器、储液器相对于透析机的高度以及透析液流量设置。例如，对于200ml/min的透析液流量且其中储液器定位在透析机的泵上方5-10英寸的情况，压力差在10mmHg的范围内。当回路R(返回)6660中的压力比回路S6670(从透析器)中的压力更高时，限流器6617限制从储液器6610的流动来进行补偿。In one embodiment, the pump head can vary from zero to over several hundred mmHg, depending on the dialyzer incorporated, the height of the reservoir relative to the dialyzer, and the dialysate flow setting. For example, for a dialysate flow rate of 200ml/min with the reservoir positioned 5-10 inches above the pump of the dialysis machine, the pressure differential is in the range of 10mmHg. When the pressure in circuit R (return) 6660 is higher than the pressure in circuit S 6670 (from dialyzer), flow restrictor 6617 restricts flow from reservoir 6610 to compensate.
在图65中的配置或图66中的配置中，有时可以具有因增加的透析器跨膜压力(TMP)导致的至透析液回路节段(分别是O6570或S6670)中的增加的流出量。例如这可能因为透析器(分别是6540或6640)的流出障碍而发生。在这种情况下，可能具有限流器(分别是6517或6617)不能足够地打开来进行调节的可能性，例如如果置换液源6510或储液器6610定位成低于泵的水平。为了应对这种情况，增压泵可以插入置换液源6510或储液器6610之后的回路中。增压泵可以配置成在差分放大器(分别是6525或6625)和/或限流器(分别是6517或6617)不能调节系统的情况下被自动打开。In either the configuration in Figure 65 or the configuration in Figure 66, there may sometimes be an increased outflow into the dialysate circuit segment (06570 or S6670, respectively) due to increased dialyzer transmembrane pressure (TMP). This may for example occur due to an outflow obstruction of the dialyzer (6540 or 6640 respectively). In this case, there may be a possibility that the flow restrictor (6517 or 6617 respectively) will not open enough to regulate, for example if the replacement fluid source 6510 or reservoir 6610 are positioned below the level of the pump. To deal with this situation, a booster pump can be inserted in the circuit after the replacement fluid source 6510 or reservoir 6610. The booster pump can be configured to be turned on automatically in the event that the differential amplifier (6525 or 6625 respectively) and/or flow restrictor (6517 or 6617 respectively) cannot regulate the system.
因为在泵交换期间产生时间间隙，所以有必要计算交换之间的时间间隔。该计算是在任何给定的时间被泵送的流体量的最大可允许差的函数，如由两个函数确定。然而，计算必须补偿向用于来自置换液容器的流体的泵以及用于从患者通过透析器返回的流体的泵呈现的压头的差。Because time gaps are created during pump exchanges, it is necessary to calculate the time interval between exchanges. This calculation is a function of the maximum allowable difference in the amount of fluid being pumped at any given time, as determined by the two functions. However, the calculation must compensate for the difference in pressure heads presented to the pumps for fluid from the replacement fluid container and for fluid returning from the patient through the dialyzer.
泵被交换的频率取决于对于任何给定间隔T在透析过程期间患者中的流体体积的最大可接受的增加或减小。例如，如果可允许的净增益或损失是200ml并且置换液正在以200ml/min的速率输入，则用于两个泵的泵送速率的差的各种水平的泵交换频率在图67的表格6700中得到详细描述。How often the pump is exchanged depends on the maximum acceptable increase or decrease in fluid volume in the patient during the dialysis session for any given interval T. For example, if the allowable net gain or loss is 200ml and the replacement fluid is being fed in at a rate of 200ml/min, the pump swap frequencies for various levels of difference in the pumping rates of the two pumps are shown in table 6700 of FIG. 67 are described in detail.
以下描述涉及在图65中示出的实施方案中的部件，但是以与图66中所示实施方案的相同方式同样适用。参照图67，表格的第一行670l示出了当两个泵(泵A6545和泵B6555)的泵送速率的百分数差是l％(这相当于2ml的流体体积差(对于200ml的可允许净增益或损失))时，那么以200ml/2ml＝l00分钟的时间间隔交换泵将实现零体积差。类似地，对于2％的泵送速率差来说，以200ml/4ml＝50分钟的间隔交换泵将实现体积平衡等等。这在表格6700的后续行中示出。The following description refers to components in the embodiment shown in FIG. 65 , but applies equally in the same manner as the embodiment shown in FIG. 66 . Referring to Figure 67, the first row 6701 of the table shows when the percentage difference in the pumping rates of the two pumps (pump A6545 and pump B6555) is 1% (this corresponds to a fluid volume difference of 2ml (for an allowable net volume of 200ml) gain or loss)), then exchanging the pumps at intervals of 200ml/2ml = 100 minutes will achieve zero volume difference. Similarly, for a pumping rate difference of 2%, swapping the pumps at intervals of 200ml/4ml = 50 minutes will achieve volume balance and so on. This is shown in the subsequent rows of table 6700.
即使更严格的限制将置于可被输注入患者或从患者移除的流体的最大体积，例如与上文实施方案中的±200ml不同的±30ml，用于当泵送差是5％的情况的交换间隔将是30ml/10ml＝3分钟。因为交换泵仅需要切换二通阀(在图65示为6505)，而不需要开始和停止泵，所以甚至3分钟(或更短的)的短间隔在实践上也是可实施的。Even stricter limits would be placed on the maximum volume of fluid that can be infused into or removed from the patient, eg ±30ml as opposed to ±200ml in the above embodiment for when the pumping difference is 5% The exchange interval for the case would be 30ml/10ml = 3 minutes. Even short intervals of 3 minutes (or less) are practically achievable because swapping the pumps only requires switching the two-way valve (shown as 6505 in Figure 65) and not starting and stopping the pumps.
更频繁地交换泵还可以缓和泵管子性能中的任何分歧。因为在本发明的系统中，两个泵的管子经受相同数量的影响，所以泵的性能倾向于不偏差。Swapping the pump more frequently will also moderate any divergence in pump tubing performance. Because in the system of the present invention the tubes of both pumps are subjected to the same number of influences, the performance of the pumps tends to be unbiased.
当使用泵交换方法时，如果该过程不在偶数次的交换停止，则其可以导致置换液和输出流体的体积平衡的差别错误。因此，在一个实施方案中，系统配置成仅当偶数次的交换完成时停止，除非系统被覆写。在净差别错误中导致的问题的潜在影响还可以通过更频繁地交换泵而得到减少。在任何情况下，可以保证的是，任何净差将不在对于最大可允许的净流体损失或增益例如±200ml的最初设置的边界之外。因此，在一个实施方案中，本发明包括与所有操作性泵数据通信的控制器。控制器包括具有通过递增来追踪泵交换数量的计数器的软件。如果泵交换的数量不是偶数，那么控制器实施防止系统被关闭的闭锁信号。控制器在计数器是偶数时释放闭锁信号，从而允许系统关闭。控制器还负责传输交换信号，交换信号使合适的阀打开和关闭，从而导致泵交换。When using the pump exchange method, if the process is not stopped at an even number of exchanges, it can lead to differential errors in the volume balance of the replacement and output fluids. Thus, in one embodiment, the system is configured to stall only when an even number of swaps are complete, unless the system is overwritten. The potential impact of problems caused in net differential errors can also be reduced by exchanging pumps more frequently. In any event, it can be guaranteed that any net difference will not be outside the initially set boundaries for the maximum allowable net fluid loss or gain, eg ±200ml. Thus, in one embodiment, the present invention includes a controller in data communication with all operative pumps. The controller includes software with a counter that increments to track the number of pump swaps. If the number of pump swaps is not even, the controller implements a lockout signal that prevents the system from being shut down. The controller releases the latch signal when the counter is even, allowing the system to shut down. The controller is also responsible for transmitting the handshake signals that cause the appropriate valves to open and close, resulting in pump handshakes.
在泵交换的过程期间，将具有少量残留的流体从一个子回路移至另一个子回路。例如，如果蠕动泵管路是0.8ml/英寸并且泵-管子节段长度是3英寸，则残留物将是每时间段2.4ml(3英寸×0.8ml/英寸＝2.4m1)。在50分钟的示例性时间段内并且采用200ml/min的泵送速率，将泵送10升的流体(50min×200ml/min＝10000m1)。因此，以升计的残留物与被泵送的总流体的百分数是仅0.024％(2.4ml/10000ml＝0.024％)。甚至残留物的这种小的百分数的影响将被消除，因为在子回路之间的移动因泵交换而发生，这抵消净效果。During the process of pump exchange, fluid with a small amount of residue is moved from one sub-circuit to the other. For example, if the peristaltic pump tubing is 0.8ml/inch and the pump-tubing segment length is 3 inches, the residue will be 2.4ml per time period (3 inches x 0.8ml/inch = 2.4ml). During an exemplary time period of 50 minutes and using a pumping rate of 200ml/min, 10 liters of fluid will be pumped (50min x 200ml/min = 10000ml). Thus, the percentage of residue in liters to total fluid pumped is only 0.024% (2.4ml/10000ml = 0.024%). The effect of even such a small percentage of residue will be eliminated as movement between sub-circuits occurs due to pump exchange, which cancels out the net effect.
关于残留流体从一个子回路进入另一个子回路中的问题，从透析器出来的流体仅来自患者，因此，将该流体与无菌置换液共同回推到患者中非常安全。Regarding the issue of residual fluid going from one subcircuit into the other, the fluid coming out of the dialyzer comes only from the patient, so it is perfectly safe to push that fluid back into the patient along with the sterile replacement fluid.
如上文所提到，在透析期间，如果需要的话，另外的流体可以以超滤液(UF)的形式从患者移除，并且为了本目的，在本发明的系统中提供UF泵。此外，体积精确度得到保持，而与UF被移除的体积的多少无关。As mentioned above, during dialysis, additional fluid can be removed from the patient in the form of ultrafiltrate (UF) if required, and for this purpose a UF pump is provided in the system of the invention. Furthermore, volumetric accuracy is maintained regardless of how much volume is removed by UF.
当泵送出超滤液以从患者移除过量的流体时，如果系统具有较低的泵速率，例如与高速率例如200ml/min不同的10ml/min的数量级，那么实现限定的总体积精确度更加容易。例如如果所需的精确度是±30ml，那么在60分钟的时间段上，600ml将按10ml/min的泵速率泵送。这暗示所实现的百分数精确度是30ml/600ml＝.05或5％，这是合理获得的。然而，本领域技术人员要理解的是，本发明的系统能够实现期望的体积精确度，而与透析装置中的UF泵的泵速率无关。When pumping out ultrafiltrate to remove excess fluid from the patient, if the system has a lower pump rate, for example on the order of 10 ml/min as opposed to a high rate, e.g. 200 ml/min, then a defined total volume accuracy is achieved much easier. For example if the desired accuracy is ±30ml, then over a period of 60 minutes 600ml will be pumped at a pump rate of 10ml/min. This implies that the percent accuracy achieved is 30ml/600ml = .05 or 5%, which is reasonably achievable. However, it will be understood by those skilled in the art that the system of the present invention is capable of achieving the desired volumetric accuracy independent of the pump rate of the UF pump in the dialysis device.
一次性电导传感器Disposable conductivity sensor
除了其他元件之外，图86示出了一次性电导传感器8690，其包括具有用于接收第一一次性管路节段的第一端部和用于接收第二一次性管路节段的第二端部的管状片段。管状片段包括第一多个探针，它们延伸到由管状片段限定的内部体积中并且构成流体流动路径。在一个实施方案中，至少采用三个分离的细长探针。在另一个实施方案中，至少采用四个分离的细长探针。Figure 86 shows, among other elements, a disposable conductivity sensor 8690 comprising a first end for receiving a first disposable tubing segment and a second end for receiving a second disposable tubing segment. the tubular segment at the second end of the The tubular segment includes a first plurality of probes extending into the interior volume defined by the tubular segment and forming a fluid flow path. In one embodiment, at least three separate elongated probes are employed. In another embodiment, at least four separate elongate probes are employed.
一次性电导传感器8690适应于附接到被固定地和/或永久地附接到控制单元外侧的互补匹配的第二多个探针。优选地，附接的部位包括控制单元外部表面的紧邻于透析器的或与其同侧上的部分，如上文参照图l所述。操作性地，一次性电导传感器8690被扣接成与互补匹配的非一次性多个探针的暂时但被附接的关系。因此，第二多个探针容纳到第一多个探针中并且定位成与它们连通。探针然后通过以下而进行操作：发射并且探测在由第一一次性管路节段、电导传感器的管状片段以及第二一次性管路节段限定的流体流动路径内的信号，如之前在本文中讨论，并且然后将探测到的信号传输至控制单元内的存储器和处理器来用于监视和控制透析系统。The disposable conductivity sensor 8690 is adapted to be attached to a complementary mating second plurality of probes that are fixedly and/or permanently attached to the outside of the control unit. Preferably, the site of attachment comprises a portion of the external surface of the control unit immediately adjacent to or on the same side as the dialyzer, as described above with reference to FIG. 1 . Operationally, the disposable conductance sensor 8690 is snapped into temporary but attached relationship with complementary mating non-disposable plurality of probes. Accordingly, the second plurality of probes is received into the first plurality of probes and positioned in communication therewith. The probe then operates by emitting and detecting signals within the fluid flow path defined by the first disposable tubing segment, the tubular segment of the conductivity sensor, and the second disposable tubing segment, as before Discussed herein, and the detected signals are then transmitted to a memory and processor within the control unit for monitoring and controlling the dialysis system.
阀系统valve system
为了允许控制流过血液和透析液回路并且为了选择期望的操作模式(血液透析或血液滤过)，在一个实施方案中，系统设置有二通阀，如上文描述。这些阀可以由用户致动以在一个操作模式下引导透析液流动通过透析器或以在第二操作模式下将输注液级透析液流动直接递送至患者。这些二通阀也可以与透析回路的紧凑歧管集成。这在图68中示出。还应当注意的是，在图68至70中，为了清楚的目的，相应的元件具有相同的标号。To allow control of the flow through the blood and dialysate circuit and to select the desired mode of operation (hemodialysis or hemofiltration), in one embodiment the system is provided with a two-way valve, as described above. These valves can be actuated by the user to direct the flow of dialysate through the dialyzer in one mode of operation or to deliver the flow of infusion-grade dialysate directly to the patient in a second mode of operation. These 2-way valves can also be integrated with the compact manifold of the dialysis circuit. This is shown in Figure 68. It should also be noted that in Figures 68 to 70, corresponding elements have been given the same reference numerals for purposes of clarity.
参照图68，体外血液处理系统6800包括塑料模制的紧凑歧管6810，其包封多个模制的血液及透析液流体路径以及多个传感器区域、阀和流体泵节段。透析器6805在连接到歧管6810的动脉血管子680l和静脉血管子6802时完成系统6800的血液回路。在一个实施方案中，透析器6805是一次性的。两个管线6803和6804用于分别循环已消耗的透析液和新鲜的透析液。为了在两个模式(血液透析和血液滤过)中的任一个下操作系统6800，二通阀6845和备用二通阀6846被提供。Referring to FIG. 68, an extracorporeal blood treatment system 6800 includes a plastic molded compact manifold 6810 enclosing multiple molded blood and dialysate fluid paths as well as multiple sensor areas, valves, and fluid pump segments. The dialyzer 6805 completes the blood circuit of the system 6800 when connected to the arterial sub-6801 and venous sub-6802 of the manifold 6810. In one embodiment, the dialyzer 6805 is disposable. Two lines 6803 and 6804 are used to circulate spent dialysate and fresh dialysate, respectively. To operate the system 6800 in either of two modes (hemodialysis and hemofiltration), a two-way valve 6845 and a backup two-way valve 6846 are provided.
采用了备用阀6846，因为在血液透析中使用的透析液不是无菌的并且不是输注级的，而在血液滤过中使用的流体是。如果在血液透析模式中操作或如果具有阀6845的泄漏或其他故障，那么阀6846提供抵抗流体被泵送到患者血流中的双重保护。采用备用阀6846允许安全使用一个歧管来用于血液透析和血液滤过。如上文指出，二通阀例如备用阀6846由两个单一阀组成。在这种情况下，两个单向阀是串联的，这样通过关闭二通阀6846的两个端口，给予双重保护，防止透析液进入血流。在一个可选择的实施方案中，歧管可以被制造为仅意图用于血液透析，在透析流体回路和血液回路之间没有连接，从而允许阀6846被安全地消除。The backup valve 6846 is employed because the dialysate used in hemodialysis is not sterile and not infusion grade, whereas the fluid used in hemofiltration is. If operating in hemodialysis mode or if there is a leak or other failure of valve 6845, valve 6846 provides double protection against fluid being pumped into the patient's bloodstream. Employing a spare valve 6846 allows safe use of one manifold for both hemodialysis and hemofiltration. As noted above, a two-way valve such as backup valve 6846 is composed of two single valves. In this case, the two one-way valves are in series, thus giving double protection against dialysate entering the bloodstream by closing both ports of the two-way valve 6846. In an alternative embodiment, the manifold may be manufactured intended for hemodialysis only, with no connection between the dialysis fluid circuit and the blood circuit, allowing valve 6846 to be safely eliminated.
图69A更详细地示出了根据本发明一个实施方案的用于血液透析/血液滤过系统的回路。已消耗的透析液管子和新鲜的透析液管子6903和6904分别连接到透析液再生系统6906，从而完成系统6900的透析液回路。透析液再生系统6906还包括一次性吸附剂盒6915以及用于保持由盒6915清洁的透析液的储液器6934。参照图69B，对图69A中示出的系统其他部件进行解释，图69B示出了配置成在血液透析模式下操作的体外血液处理系统6900的分解图。图69A、69B和69C中的相应元件具有相同的标号。Figure 69A shows in more detail a circuit for a hemodialysis/hemofiltration system, according to one embodiment of the present invention. Spent dialysate tubing and fresh dialysate tubing 6903 and 6904, respectively, are connected to dialysate regeneration system 6906, thereby completing the dialysate circuit of system 6900. The dialysate regeneration system 6906 also includes a disposable sorbent cartridge 6915 and a reservoir 6934 for holding dialysate cleaned from the cartridge 6915 . Other components of the system shown in FIG. 69A are explained with reference to FIG. 69B , which shows an exploded view of an extracorporeal blood treatment system 6900 configured to operate in a hemodialysis mode. Corresponding elements in Figures 69A, 69B and 69C have the same reference numerals.
血液回路6920包括蠕动血液泵692l，其将患者的动脉不纯血液沿着管子690l抽取并且将血液泵送通过透析器6905。注射器装置6907将抗凝剂例如肝素注射到抽取的不纯血流中。压力传感器6908放置在血液泵692l的入口处，并且压力传感器6909和6911放置在透析器6905的上游和下游以监视在这些优势点处的压力。Blood circuit 6920 includes a peristaltic blood pump 6921 that draws the patient's arterially impure blood along tubing 6901 and pumps the blood through dialyzer 6905 . The injector assembly 6907 injects an anticoagulant, such as heparin, into the drawn impure blood stream. Pressure sensor 6908 is placed at the inlet of blood pump 6921, and pressure sensors 6909 and 6911 are placed upstream and downstream of dialyzer 6905 to monitor the pressure at these vantage points.
随着已净化的血液从透析器6905向下游流动并且返回至患者，血液温度传感器6912设置在管线中以保持追踪已净化的血液的温度。空气消除器6913也设置成从透析器移除清洁血液中的积聚的气泡。一对空气(气泡)传感器(或可选地单一传感器)6914和夹管阀6916在回路中采用以防止积聚的气体返回至患者。A blood temperature sensor 6912 is provided in line to keep track of the temperature of the purified blood as it flows downstream from the dialyzer 6905 and back to the patient. An air eliminator 6913 is also provided to remove accumulated air bubbles in the cleaned blood from the dialyzer. A pair of air (bubble) sensors (or optionally a single sensor) 6914 and a pinch valve 6916 are employed in the circuit to prevent accumulated gas from returning to the patient.
透析液回路6925包括两个双通道脉动透析液泵6926、6927。透析液泵6926、6927分别从透析器6905抽取已消耗的透析液溶液以及从储液器6934抽取已再生的透析液溶液。在来自透析器6905的使用过的透析液流体进入透析液回路6925的点处，血液泄漏传感器6928设置成感测并且防止血液任何泄漏到透析液回路中。来自透析器6905出口的已消耗的透析液然穿过旁通阀6929以到达二通阀6930。压力传感器693l放置在阀6929和6930之间。超滤液泵6932设置在透析液回路中，超滤液泵被周期性地操作以从已消耗的透析液抽取超滤液废物并且将其储存在被周期性排空的超滤液袋6933中。The dialysate circuit 6925 includes two dual channel pulsatile dialysate pumps 6926, 6927. Dialysate pumps 6926, 6927 draw spent dialysate solution from dialyzer 6905 and regenerated dialysate solution from reservoir 6934, respectively. At the point where used dialysate fluid from the dialyzer 6905 enters the dialysate circuit 6925, a blood leak sensor 6928 is provided to sense and prevent any leakage of blood into the dialysate circuit. Spent dialysate from the outlet of dialyzer 6905 passes through bypass valve 6929 to two-way valve 6930. A pressure sensor 6931 is placed between valves 6929 and 6930. An ultrafiltrate pump 6932 is provided in the dialysate circuit which is operated periodically to draw ultrafiltrate waste from spent dialysate and store it in an ultrafiltrate bag 6933 which is periodically emptied .
如上文提到，通过使用吸附剂盒来再生已消耗的透析液。通过吸附剂盒6915再生的透析液被收集在储液器6934中。储液器6934分别包括电导传感器和氨传感器696l和6962。从储液器6934，已再生的透析液穿过限流器6935和压力传感器6936以到达二通阀6937。取决于患者要求，可以将期望量的来自储液器6950的输注溶液和/或来自储液器695l的浓缩溶液加入到透析流体中。输注液和浓缩液是含有有助于将透析液流体中的矿物质例如钾和钙保持在由医师规定的水平的矿物质和/或葡萄糖的无菌溶液。旁通阀694l和蠕动泵6942设置成选择输注液和/或浓缩溶液的期望量以及确保该溶液适当流动到从储液器6934发出的已清洁的透析液中。As mentioned above, spent dialysate is regenerated by using a sorbent cartridge. Dialysate regenerated by sorbent cartridge 6915 is collected in reservoir 6934. Reservoir 6934 includes conductivity and ammonia sensors 6961 and 6962, respectively. From reservoir 6934, regenerated dialysate passes through flow restrictor 6935 and pressure sensor 6936 to two-way valve 6937. Depending on patient requirements, desired amounts of infusion solution from reservoir 6950 and/or concentrated solution from reservoir 6951 may be added to the dialysis fluid. Infusions and concentrates are sterile solutions containing minerals and/or glucose that help maintain minerals such as potassium and calcium in the dialysate fluid at levels prescribed by a physician. Bypass valve 6941 and peristaltic pump 6942 are configured to select the desired volume of infusate and/or concentrate solution and to ensure proper flow of this solution into the cleaned dialysate emanating from reservoir 6934.
透析液回路包括两个二通阀6930和6937。阀6930将已消耗的透析液的一个流引导至透析液泵6926的第一通道并且将已消耗的透析液的另一个流引导至透析液泵6927的第一通道。类似地，阀6937将已再生的透析液的一个流引导至透析液泵6926的第二通道并且将已再生的透析液的另一个流引导至透析液泵6927的第二通道。The dialysate circuit includes two two-way valves 6930 and 6937. Valve 6930 directs one flow of spent dialysate to a first channel of dialysate pump 6926 and the other flow of spent dialysate to a first channel of dialysate pump 6927 . Similarly, valve 6937 directs one flow of regenerated dialysate to the second channel of dialysate pump 6926 and the other flow of regenerated dialysate to the second channel of dialysate pump 6927 .
来自泵6926和6927的已消耗的透析液的流由二通阀6938收集，并且来自泵6926和6927的已再生的透析液的流由二通阀6939收集。阀6938将已消耗的透析液的两个流组合为单一流，该单一流被泵送经由压力传感器6940并且通过吸附剂盒6915，其中已消耗的透析液被清洁和过滤，然后被收集在储液器6934中。阀6939将已再生的透析液的两个流组合为单一流，该单一流通过旁通阀6947流动至二通阀6945。压力传感器6943和透析液温度传感器6944设置在至二通阀6945的透析液流动流上。The flow of spent dialysate from pumps 6926 and 6927 is collected by two-way valve 6938 , and the flow of regenerated dialysate from pumps 6926 and 6927 is collected by two-way valve 6939 . Valve 6938 combines the two streams of spent dialysate into a single stream that is pumped through pressure sensor 6940 and through sorbent cartridge 6915 where the spent dialysate is cleaned and filtered before being collected in a reservoir. Liquid container 6934. Valve 6939 combines the two streams of regenerated dialysate into a single stream that flows through bypass valve 6947 to 2-way valve 6945. A pressure sensor 6943 and a dialysate temperature sensor 6944 are provided on the dialysate flow stream to the two-way valve 6945 .
通过反转二通阀6930、6937、6938和6939的状态，两个泵6926和6927就它们的一个从透析器6905抽出透析流体并且另一个将透析流体供应至透析器6905的动作而言反转。这样的反转在被周期性地进行经过相对于透析过程短的时间段时确保在整个透析过程的较长时间段上被泵送到透析器中的透析液流体体积等于被泵送出的流体量并且由透析回路6925损失的仅总流体体积是由超滤液泵6932移除的体积，如上文所讨论。By reversing the state of the two-way valves 6930, 6937, 6938 and 6939, the two pumps 6926 and 6927 are reversed with respect to their action of one drawing dialysis fluid from the dialyzer 6905 and the other supplying dialysis fluid to the dialyzer 6905 . Such inversion, when performed periodically over a short period of time relative to the dialysis session, ensures that the volume of dialysate fluid pumped into the dialyzer is equal to the fluid pumped out over a longer period of time throughout the dialysis session. The only total fluid volume lost and lost by the dialysis circuit 6925 is the volume removed by the ultrafiltrate pump 6932, as discussed above.
在血液透析模式中，二通阀6945允许已再生的透析液进入透析器6905以使患者血液的正常血液透析成为可能。阀6945通往患者血液返回管线的一侧被关闭。另一个二通阀6946用作备用，保持透析液远离患者的血液管线，使阀6946的两个端口在即使阀6945泄漏或故障时也关闭。In hemodialysis mode, the two-way valve 6945 allows regenerated dialysate to enter the dialyzer 6905 to enable normal hemodialysis of the patient's blood. The side of valve 6945 leading to the patient blood return line is closed. Another two-way valve 6946 is used as a backup to keep the dialysate away from the patient's blood line, keeping both ports of the valve 6946 closed even if the valve 6945 leaks or fails.
参照图69C，在血液滤过模式下，二通阀6945可被致动以将新鲜的超高纯透析液的流从储液器6952引导通过阀6946，现在使两个端口都打开以直接进入从透析器发出的已净化的血液的流并且流动返回至患者。Referring to Figure 69C, in the hemofiltration mode, the two-way valve 6945 can be actuated to direct the flow of fresh ultra-high purity dialysate from the reservoir 6952 through the valve 6946, now leaving both ports open for direct access A flow of purified blood originates from the dialyzer and flows back to the patient.
本领域技术人员应当注意的是，备用二通阀6946是冗余安全阀，以确保在血液透析模式下一个阀6945的故障不导致已再生的透析液的直接输注到患者中。也就是说，阀6945和6946能够被该系统致动以允许流体被引导至患者的静脉血管线作为安全性考虑。在一个实施方案中，二通备用阀6946是单一阀，以允许或停止流体流动。It should be noted by those skilled in the art that the backup 2-way valve 6946 is a redundant safety valve to ensure that failure of one valve 6945 in hemodialysis mode does not result in direct infusion of regenerated dialysate into the patient. That is, valves 6945 and 6946 can be actuated by the system to allow fluid to be directed to the patient's venous line as a safety consideration. In one embodiment, the 2-way backup valve 6946 is a single valve to allow or stop fluid flow.
本领域技术人员应当进一步注意的是，如在上文说明书中描述的阀被称为‘旁通’或‘二通’，这取决于它们的用途。因此，阀在它们绕过部件例如透析器时被称为‘旁通阀’。否则它们被称为‘二通阀’，并且简单地将流动在至少两个方向上引导。然而，旁通阀和二通阀可以在构造上是相同的。Those skilled in the art should further note that valves as described in the specification above are referred to as 'bypass' or 'two-way', depending on their use. Valves are therefore called 'bypass valves' when they bypass components such as dialyzers. Otherwise they are known as '2-way valves' and simply direct flow in at least two directions. However, the bypass valve and the two-way valve may be identical in construction.
在一个实施方案中，用于本发明的二通阀被制造为弹性体膜，其由容纳在透析机内的机构压靠着孔口，以停止流动流与流体回路其余部分的流体接触，如下文进一步讨论。In one embodiment, the two-way valve used in the present invention is fabricated as an elastomeric membrane that is pressed against the orifice by a mechanism housed within the dialysis machine to stop fluid contact of the flow stream with the remainder of the fluid circuit, as follows The text discusses further.
二通阀6945和6946可以用于改变血液处理系统的操作模式。参照图69C，描绘了血液及透析液回路6920和6925中的流体流动。因为系统正在血液滤过模式下操作，所以已消耗的透析液管6903连接到排放部，而新鲜的透析液管子6904连接到新鲜的超纯且可注射级透析液储液器6952。通过球阀滴室6953的新鲜透析液穿过加热器袋6954以流入新鲜透析液管子6904。血液及透析液回路6920、6925的元件和流体路径的其余部分类似于图69B，不同之处在于在血液滤过中新鲜的透析液或置换液被引入到透析液回路6925中，因为已消耗的透析液被排放并且不被反复使用。此外，在输注液子系统中，部件6942、6950、6941和6951未被使用。Two-way valves 6945 and 6946 can be used to change the operating mode of the blood treatment system. Referring to Figure 69C, fluid flow in blood and dialysate circuits 6920 and 6925 is depicted. Because the system is operating in hemofiltration mode, spent dialysate line 6903 is connected to the drain, while fresh dialysate line 6904 is connected to fresh ultrapure and injectable grade dialysate reservoir 6952 . Fresh dialysate passing through ball valve drip chamber 6953 passes through heater bag 6954 to flow into fresh dialysate tubing 6904. The components of the blood and dialysate circuits 6920, 6925 and the rest of the fluid pathways are similar to FIG. 69B, except that in hemofiltration fresh dialysate or replacement fluid is introduced into the dialysate circuit 6925 because the spent Dialysate is drained and not reused. Also, in the infusion fluid subsystem, components 6942, 6950, 6941 and 6951 are not used.
血液回路6920包括沿着管子690l抽取患者动脉不纯血液并且将血液泵送通过透析器6905的蠕动血液泵692l。可选择的泵6907将抗凝剂例如肝素注射到被抽取的不纯血流中。压力传感器6908放置在血液泵692l的入口处，而压力传感器6909和6911放置在透析器6905的上游和下游。来自透析器6905的已净化的血液被泵送通过管子6902经过血液温度传感器6912、空气消除器6913和空气(气泡)传感器6914并且返回至患者的静脉。夹管阀6916也被放置成完全停止血液流动，如果空气被管线中在夹管阀6916上游的气泡传感器6914感测到的话，从而防止空气到达患者。The blood circuit 6920 includes a peristaltic blood pump 6921 that draws impure arterial blood of the patient along tubing 6901 and pumps the blood through the dialyzer 6905 . An optional pump 6907 injects an anticoagulant such as heparin into the drawn impure blood stream. Pressure sensor 6908 is placed at the inlet of blood pump 6921, while pressure sensors 6909 and 6911 are placed upstream and downstream of dialyzer 6905. Purified blood from dialyzer 6905 is pumped through tubing 6902 past blood temperature sensor 6912, air eliminator 6913 and air (bubble) sensor 6914 and back to the patient's vein. The pinch valve 6916 is also placed to completely stop blood flow if air is sensed by the air bubble sensor 6914 in the line upstream of the pinch valve 6916, thereby preventing air from reaching the patient.
透析液回路6925包括两个双通道透析液泵6926、6927。透析液泵6926、6927分别从透析器6905抽取已消耗的透析液溶液以及从储液器6952抽取新鲜的透析液溶液。来自透析器6905出口的已消耗的透析液被抽取通过血液泄漏传感器6928和旁通阀6929以到达二通阀6930。压力传感器693l放置在阀6929和6930之间。超滤液泵6932被周期性地操作以从已消耗的透析液抽取超滤液废物并且将其储存在超滤液袋6933(其被周期性地排空)中。来自储液器6952的新鲜透析液穿过限流器6935和压力传感器6936以到达二通阀6937。本领域技术人员要理解的是，在本方案中，不需要输注液和浓缩液，并且可以不使用与这些功能相关的元件694l、6942、6950、695l。The dialysate circuit 6925 includes two dual channel dialysate pumps 6926, 6927. Dialysate pumps 6926, 6927 draw spent dialysate solution from dialyzer 6905 and fresh dialysate solution from reservoir 6952, respectively. Spent dialysate from the dialyzer 6905 outlet is drawn through blood leak sensor 6928 and bypass valve 6929 to two-way valve 6930. A pressure sensor 6931 is placed between valves 6929 and 6930. The ultrafiltrate pump 6932 is operated periodically to draw ultrafiltrate waste from spent dialysate and store it in the ultrafiltrate bag 6933 (which is periodically emptied). Fresh dialysate from reservoir 6952 passes through flow restrictor 6935 and pressure sensor 6936 to two-way valve 6937. It will be appreciated by those skilled in the art that in this protocol, infusates and concentrates are not required and elements 6941, 6942, 6950, 6951 associated with these functions may not be used.
加热器袋6954足够地提升新鲜透析液的温度，使得从透析器6905运动返回至患者的已超滤的血液的温度或来自透析器6905的已超滤的血液和通过致动阀6945、6946被直接输注到已净化的血液中的新鲜透析液的混合物的总体温度等效于患者的体温，从而防止任何热冲击。The heater bag 6954 elevates the temperature of the fresh dialysate sufficiently that the temperature of the ultrafiltered blood moving back to the patient from the dialyzer 6905 or the ultrafiltered blood from the dialyzer 6905 is heated by the actuated valves 6945, 6946. The bulk temperature of the mixture of fresh dialysate infused directly into the purified blood is equivalent to the patient's body temperature, preventing any thermal shock.
图70示出了流体回路的可选择的实施方案，其中不使用备用二通阀6946。血液回路包括蠕动血液泵，其沿着管子700l抽取患者的动脉不纯血液并且将血液泵送通过透析器7005。注射器或泵7007将抗凝剂例如肝素注射到被抽取的不纯血流中。压力传感器7008放置在血液泵的入口处，并且压力传感器7009和7011放置在歧管节段的上游和下游。来自透析器7005的已净化血液被泵送通过管子7002经过血液温度传感器7012、空气消除器7013和空气(气泡)传感器7014并且返回至患者的静脉。夹管阀7016也放置在至患者的回路连接之前，以在空气被管线中在夹管阀7016上游的空气(气泡)传感器7014感测到时完全停止血液流动，从而防止空气到达患者。Figure 70 shows an alternative embodiment of the fluid circuit in which the backup two-way valve 6946 is not used. The blood circuit includes a peristaltic blood pump that draws the patient's arterial impure blood along tubing 7001 and pumps the blood through a dialyzer 7005 . A syringe or pump 7007 injects an anticoagulant, such as heparin, into the drawn impure blood stream. Pressure sensor 7008 is placed at the inlet of the blood pump, and pressure sensors 7009 and 7011 are placed upstream and downstream of the manifold segment. Purified blood from dialyzer 7005 is pumped through tubing 7002 past blood temperature sensor 7012, air eliminator 7013 and air (bubble) sensor 7014 and back to the patient's vein. A pinch valve 7016 is also placed prior to the circuit connection to the patient to completely stop blood flow when air is sensed by the air (bubble) sensor 7014 in the line upstream of the pinch valve 7016, thereby preventing air from reaching the patient.
透析液回路7010包括与泵压力连通的两个透析液泵节段7026、7027。透析液泵节段7026、7027分别从透析器7005抽取已消耗的透析液溶液以及从储液器7034抽取已再生的透析液溶液。来自透析器7005出口的已消耗的透析液被抽取通过血液泄漏传感器7028以到达旁通阀7029。流量传感器7020是确定流动经过回路的透析液的体积的两个流量传感器之一(另一个是流量传感器7046)。阀7030在构造上与二通阀类似并且用于绕过透析液泵7026。阀7030通常在绕过的方向上关闭。在透析液泵7026被停止的情况下，阀7030被打开以将流体流引导绕过泵7026。压力传感器703l放置在流量传感器7020和阀7030之间。在正常的流动期间，已消耗的透析液被泵送通过压力传感器7040、管子7003和吸附剂盒7015，其中已消耗的透析液被清洁和过滤。已清洁的/已过滤的透析液然后进入储液器7034。超滤液泵7032被周期性地操作以从已消耗的透析液抽取超滤液废物并且储存在被周期性排空的超滤液袋(未示出)中。The dialysate circuit 7010 includes two dialysate pump segments 7026, 7027 in pressure communication with the pumps. Dialysate pump segments 7026, 7027 draw spent dialysate solution from dialyzer 7005 and regenerated dialysate solution from reservoir 7034, respectively. Spent dialysate from the dialyzer 7005 outlet is drawn through the blood leak sensor 7028 to the bypass valve 7029. Flow sensor 7020 is one of two flow sensors (the other being flow sensor 7046) that determine the volume of dialysate flowing through the circuit. Valve 7030 is similar in construction to a 2-way valve and is used to bypass dialysate pump 7026 . Valve 7030 is normally closed in the bypass direction. With the dialysate pump 7026 stopped, the valve 7030 is opened to direct fluid flow around the pump 7026 . A pressure sensor 7031 is placed between the flow sensor 7020 and the valve 7030. During normal flow, spent dialysate is pumped through pressure sensor 7040, tubing 7003, and sorbent cartridge 7015, where the spent dialysate is cleaned and filtered. The cleaned/filtered dialysate then enters reservoir 7034. The ultrafiltrate pump 7032 is operated periodically to draw ultrafiltrate waste from spent dialysate and store in a periodically emptied ultrafiltrate bag (not shown).
来自储液器7034的已再生的透析液穿过管子7004、限流器7035、透析液温度传感器7044、流量传感器7046和压力传感器7036以通过旁通阀704l到达二通阀7045。当旁通阀7029、7045和704l的相应流动路径被激活时，它们引导已再生的透析液绕过透析器7005。来自输注液和浓缩液储液器7050、705l的输注液流和浓缩液流分别由输注液泵节段和浓缩液泵节段7042、7043引导到经由管子7037从储液器7034发出的已清洁的透析液中和在流量传感器7020下游的已消耗的透析液中。Regenerated dialysate from reservoir 7034 passes through tubing 7004, flow restrictor 7035, dialysate temperature sensor 7044, flow sensor 7046, and pressure sensor 7036 to pass through bypass valve 7041 to two-way valve 7045. Bypass valves 7029, 7045, and 7041 direct regenerated dialysate to bypass dialyzer 7005 when their respective flow paths are activated. The infusate and concentrate streams from the infusate and concentrate reservoirs 7050, 7051 are directed by the infusate and concentrate pump segments 7042, 7043, respectively, to exit the reservoir 7034 via tubing 7037 In the cleaned dialysate and in the spent dialysate downstream of the flow sensor 7020.
二通阀7045决定系统在什么模式下操作。因此，在一个操作模式中，二通阀7045允许已再生的透析液经由管子7060进入透析器以使患者血液的正常血液透析成为可能。在另一个操作模式中，二通阀7045被致动以将超纯输注液级透析流体的流体流动导入静脉血管线中并且直接引导至患者。因此，这种多用途阀使得操作模式能够在血液滤过和血液透析之间切换。例如，在图69C所示的血液滤过中，可输注级流体被引导通过三个阀直接进入阀6946连接到后透析器处的血流中。在该模式下，阀6945防止透析液流体进入透析器的下端口。如图69B所示，在血液透析中，阀6946关闭，且阀6947和6945将透析液流体引导至透析器。应当注意的是，图69B的实施方案使用泵交换和多个阀来控制流体体积，而图70的实施方案使用流量传感器7020和7046来控制流体体积。The two-way valve 7045 determines in what mode the system operates. Thus, in one mode of operation, the two-way valve 7045 allows regenerated dialysate to enter the dialyzer via tubing 7060 to enable normal hemodialysis of the patient's blood. In another mode of operation, the two-way valve 7045 is actuated to direct fluid flow of ultrapure infusion grade dialysis fluid into the venous line and directly to the patient. Thus, such a multipurpose valve enables the mode of operation to be switched between hemofiltration and hemodialysis. For example, in the hemofiltration shown in Figure 69C, infusible grade fluid is directed through three valves directly into the blood stream where valve 6946 is connected to the post-dialyzer. In this mode, valve 6945 prevents dialysate fluid from entering the lower port of the dialyzer. As shown in Figure 69B, during hemodialysis, valve 6946 is closed and valves 6947 and 6945 direct dialysate fluid to the dialyzer. It should be noted that the embodiment of FIG. 69B uses pump exchange and multiple valves to control fluid volume, while the embodiment of FIG. 70 uses flow sensors 7020 and 7046 to control fluid volume.
如上文讨论，阀优选地通过使用在根据需要的从歧管机器延伸的突出部、针或其他构件选择性闭塞的流动控制点处的弹性膜而在歧管中得到实施。在一个实施方案中，流体闭塞通过使用安全低能量磁力阀来实现。As discussed above, the valves are preferably implemented in the manifold using elastic membranes at flow control points that are selectively occluded as desired by protrusions, needles or other members extending from the manifold machine. In one embodiment, fluid occlusion is achieved through the use of a safe low energy magnetic valve.
阀系统包括轻量且消耗最小功率的磁位移系统，使其甚至当便携式肾脏透析系统使用用于流体回路的一次性歧管时也是理想的。该系统可以结合任何结构中的孔口共同使用。特别地，孔口是在任何类型材料中的任何孔、开口、空穴或分隔部。这包括在管路、歧管、一次性歧管、通道中的路径以及其他路径。本领域技术人员要理解的是，如下文进一步讨论，通过将位移构件和磁体定位在歧管外部在期望的阀地点处，将采用一次性歧管来实施目前公开的阀系统。致动器也与一次性歧管分离且分立，并且通常是肾脏透析系统的非一次性部分的一部分。The valve system includes a magnetic displacement system that is lightweight and consumes minimal power, making it ideal even when the portable renal dialysis system uses disposable manifolds for the fluid circuit. The system can be used with orifices in any configuration. In particular, an aperture is any hole, opening, cavity or partition in any type of material. This includes paths in lines, manifolds, disposable manifolds, channels, and others. It will be appreciated by those skilled in the art, as discussed further below, that the presently disclosed valve system will be implemented with a disposable manifold by positioning the displacement member and magnet external to the manifold at the desired valve location. The actuator is also separate and discrete from the disposable manifold and is usually part of the non-disposable portion of the kidney dialysis system.
在功能上，本发明的阀具有两个稳定状态：打开和关闭。其通过使用磁力操作以将位移构件运动为紧贴膜片且从而产生足够的力来按压膜片紧贴阀座并且使膜片关闭孔口。孔口的关闭将关闭流体流动。反转过程，即使用磁力将位移构件远离膜片运动且从而将膜片从紧贴阀座的压缩释放，打开孔口并且允许流体流动。Functionally, the valve of the present invention has two stable states: open and closed. It operates by using magnetic force to move the displacement member against the diaphragm and thereby generate sufficient force to press the diaphragm against the valve seat and cause the diaphragm to close the orifice. Closure of the orifice will shut off fluid flow. The reversal process, ie the use of magnetic force to move the displacement member away from the diaphragm and thereby release the diaphragm from compression against the seat, opens the orifice and allows fluid flow.
应当理解的是，虽然本发明应当在图7lA和7lB中描绘的优选实施方案和在图73中描绘的非优选实施方案的方面讨论，但是本发明大体上涉及阀在具有以下属性的肾脏透析系统中的任何使用：a)两个稳定状态，打开和关闭，b)改变状态需要能量输入，c)保持状态不需要能量输入，d)状态通过使用磁力来更改位移构件的位置而改变，位移构件在被更改时使阀打开或关闭。It should be understood that while the invention should be discussed in terms of the preferred embodiment depicted in Figures 71A and 71B and the non-preferred embodiment depicted in Figure 73, the invention generally relates to valves in a renal dialysis system having the following properties Any use in: a) two stable states, open and closed, b) changing state requires energy input, c) maintaining state requires no energy input, d) state is changed by using magnetic force to change the position of displacement member, displacement member Causes the valve to open or close when changed.
在一个实施方案中，参照图7lA和7lB，本发明的阀系统7l00用于控制通过流体流动通道7102的流体流动，该流体流动通道由阀座7104约束，从而产生阀环形孔口7103。孔口7103是在任何类型材料特别是歧管、一次性歧管、通道和其他路径7110中的任何孔、开口、空穴或分隔部。示出了处于开放状态的阀7100。阀系统的部件包括孔口关闭构件、位移构件、用于移动位移构件的机构、可选择的光学传感器、线圈驱动器回路以及具有线圈的致动器。In one embodiment, referring to FIGS. 71A and 71B , a valve system 7100 of the present invention is used to control fluid flow through a fluid flow channel 7102 constrained by a valve seat 7104 creating a valve annular orifice 7103 . Aperture 7103 is any hole, opening, cavity or partition in any type of material, particularly manifolds, disposable manifolds, channels, and other pathways 7110 . Valve 7100 is shown in an open state. Components of the valve system include an orifice closing member, a displacement member, a mechanism for moving the displacement member, an optional optical sensor, a coil driver circuit, and an actuator with a coil.
在一个实施方案中，孔口关闭构件包括膜片/隔膜7106，如下文讨论，该膜片在被位移构件压缩时紧贴阀座7104，从而使阀环形孔口7103关闭。在开放状态中，膜片7106的主体与阀座7104分隔缝隙7198。在一个实施方案中，膜片7106由软材料例如硅橡胶制造。膜片7106必须随时间、温度和致动保持其形状。阀7l00依赖于膜片材料7106，以在位移构件(压缩力)处于开放状态被移除时返回至其不被压缩的形状。In one embodiment, the orifice closing member includes a membrane/diaphragm 7106 which, as discussed below, presses against the valve seat 7104 when compressed by the displacement member, thereby closing the valve annular orifice 7103 . In the open state, the body of the diaphragm 7106 is separated from the valve seat 7104 by a gap 7198 . In one embodiment, diaphragm 7106 is fabricated from a soft material such as silicone rubber. The diaphragm 7106 must retain its shape over time, temperature and actuation. The valve 7100 relies on the diaphragm material 7106 to return to its uncompressed shape when the displacement member (compressive force) in the open state is removed.
本领域技术人员应当理解的是，孔口关闭构件可以包括弹簧、可压缩或不可压缩结构的任何组合，该组合在被位移构件推动时关闭孔口。在一个实施方案中，阀座7104可以模制到歧管中。对于阀座合适的材料是聚碳酸酯、ABS及类似的塑料。在优选的实施方案中，阀孔口7103的直径范围为从0.1至0.3英寸(并且更特别地0.190英寸)。可以增加孔口尺寸来增加流动以用于本发明的可选择应用，或者可选地减小来减小流动以用于可选择的应用。Those skilled in the art will appreciate that the orifice closing member may comprise any combination of springs, compressible or non-compressible structures that close the orifice when urged by the displacement member. In one embodiment, the valve seat 7104 can be molded into the manifold. Suitable materials for the valve seat are polycarbonate, ABS and similar plastics. In a preferred embodiment, the diameter of the valve orifice 7103 ranges from 0.1 to 0.3 inches (and more specifically 0.190 inches). The orifice size can be increased to increase flow for alternative applications of the invention, or alternatively decreased to decrease flow for alternative applications.
在一个实施方案中，位移构件包括柱塞帽或外壳7110，柱塞帽或外壳7110在阀处于开放状态时被紧贴膜片7106对准，但是没有基本上压缩膜片7106。定位在柱塞帽7110内的是依从性部件，例如弹簧7112和柱塞的头部7199，它们被空隙7114分隔。柱塞帽7110在外侧被流体密封部7120包围，在一个实施方案中，该流体密封部是薄软硅橡胶垫片。在一个实施方案中，柱塞帽7110被推动紧贴硅橡胶垫片并且压缩垫片以形成流体密封部7120。当处于关闭位置时，柱塞帽7110不被推动紧贴垫片，其因此不被压缩并且对于端部帽7130被松散地定位。弹簧7112是任何弹性的或依从性的材料，并且在一个实施方案中包括波形弹簧。In one embodiment, the displacement member includes a plunger cap or housing 7110 that is aligned against the diaphragm 7106 when the valve is in the open state, but does not substantially compress the diaphragm 7106. Positioned within the plunger cap 7110 are compliant components such as a spring 7112 and a head 7199 of the plunger, which are separated by a void 7114 . The plunger cap 7110 is surrounded on the outside by a fluid seal 7120, which in one embodiment is a thin soft silicone rubber gasket. In one embodiment, the plunger cap 7110 is pushed against the silicone rubber gasket and compresses the gasket to form a fluid seal 7120 . When in the closed position, the plunger cap 7110 is not pushed against the gasket, which is therefore not compressed and is loosely positioned with respect to the end cap 7130 . Spring 7112 is any elastic or compliant material, and in one embodiment includes a wave spring.
柱塞帽7110、内部弹簧7112、空气缝隙7198、柱塞头7199、柱塞体7140和芯部7142是本发明的优选位移构件的部件。在一个实施方案中，柱塞体7140具有在0.1至0.2英寸的范围内的外径(更特别地0.122英寸)并且是约0.5至2.5英寸长。应当理解的是，取决于应用，柱塞体7140是具有任何长度的任何杆结构。柱塞体7140定位在环形芯部7142(其具有一个较大的端部和一个较小的端部)内，并且通过任何本领域技术人员已知的方法附接到芯部，包括环氧树脂、螺钉附接、销钉或焊接。芯部7142的较大端部的外径在0.3英寸至0.5英寸的范围内(并且更特别地0.395英寸)，厚度在0.03至0.15英寸的范围内(并且更特别地0.05至0.10英寸)，并且长度在0.50至1.75英寸长的范围内(并且更特别地1.05英寸)。芯部7142的小端部具有0.1至0.4英寸的直径，并且更特别地0.25英寸。The plunger cap 7110, inner spring 7112, air gap 7198, plunger head 7199, plunger body 7140 and core 7142 are parts of the preferred displacement member of the present invention. In one embodiment, the plunger body 7140 has an outer diameter in the range of 0.1 to 0.2 inches (more specifically 0.122 inches) and is about 0.5 to 2.5 inches long. It should be understood that the plunger body 7140 is any rod structure of any length, depending on the application. The plunger body 7140 is positioned within an annular core 7142 (which has a larger end and a smaller end) and is attached to the core by any method known to those skilled in the art, including epoxy , screw attachment, pins or welding. The larger end of core 7142 has an outer diameter in the range of 0.3 inches to 0.5 inches (and more specifically 0.395 inches), a thickness in the range of 0.03 to 0.15 inches (and more specifically 0.05 to 0.10 inches), and The length is in the range of 0.50 to 1.75 inches long (and more particularly 1.05 inches). The small end of the core 7142 has a diameter of 0.1 to 0.4 inches, and more specifically 0.25 inches.
至少部分地包围芯部的小端部的是绕线管7195，其将线圈7148保持就位并且向线圈7148提供尺寸稳定性。缝隙优选地存在于绕线管7195和芯部7142之间。缝隙的尺寸是约0.0l至0.03英寸(并且更特别地0.02英寸)。在一个实施方案中，绕线管7195是玻璃填充的尼龙结构，其应当是非金属的且非铁磁的。绕线管7195是环形结构，其外径具有足以提供紧密配合到外壳孔中的尺寸并且其内径足以包封芯部，使得其具有用于运动和经受某个程度热膨胀的空间。两个端帽7130、7160将绕线管7195楔入就位并且防止其运动或滑动，特别是在暴露于电磁力时。At least partially surrounding the small end of the core is bobbin 7195 which holds coil 7148 in place and provides dimensional stability to coil 7148 . A gap preferably exists between bobbin 7195 and core 7142 . The size of the gap is about 0.01 to 0.03 inches (and more specifically 0.02 inches). In one embodiment, the bobbin 7195 is a glass-filled nylon structure, which should be non-metallic and non-ferromagnetic. The bobbin 7195 is an annular structure with an outer diameter of sufficient size to provide a tight fit into the housing bore and an inner diameter sufficient to enclose the core so that it has room for movement and some degree of thermal expansion. The two end caps 7130, 7160 wedge the bobbin 7195 in place and prevent it from moving or sliding, especially when exposed to electromagnetic forces.
柱塞体由金属或非金属材料例如黄铜或玻璃纤维制成，并且芯部也由金属特别是钢制造。优选地，柱塞体是非磁性的并且芯部体是铁磁性的。如下文进一步讨论，柱塞体7140和芯部7142通过用于移动位移构件的机构移动。The plunger body is made of metallic or non-metallic material such as brass or fiberglass, and the core is also made of metal, especially steel. Preferably, the plunger body is non-magnetic and the core body is ferromagnetic. As discussed further below, the plunger body 7140 and core 7142 are moved by a mechanism for moving the displacement member.
用于移动位移构件的机构包括大磁体部件、小磁体部件以及磁体和位移构件的一个部分即柱塞体7140和芯部7142包含在其内的外壳。更具体地，参照图7lA和7lB，用于移动位移构件的机构包括用于保持和对准大磁体的大磁体端帽7130、大磁体7132、弹性材料7134、缝隙7197、线圈7148、小磁体部件7162、小磁体安装部和端帽7160、以及弹性材料7164。The mechanism for moving the displacement member includes a large magnet part, a small magnet part and a housing within which the magnets and one part of the displacement member, the plunger body 7140 and the core 7142, are contained. More specifically, referring to Figures 71A and 71B, the mechanism for moving the displacement member includes a large magnet end cap 7130 for holding and aligning the large magnet, a large magnet 7132, an elastic material 7134, a gap 7197, a coil 7148, a small magnet assembly 7162, small magnet mount and end cap 7160, and resilient material 7164.
大磁体端帽7130将大磁体部件7132和绕线管7195在外壳7170内保持和对准就位，被称为致动器主体，其具有本文描述的部件被放置穿过的孔。大磁体部件7132需要与芯部7142、柱塞体7140和小磁性部件7162适当地对准以确保位移构件的合适运动。端帽7130和7160将绕线管7195和线圈7148固定就位。The large magnet end cap 7130 holds and aligns the large magnet assembly 7132 and bobbin 7195 in place within the housing 7170, referred to as the actuator body, which has a hole through which the components described herein are placed. The large magnet part 7132 needs to be properly aligned with the core 7142, plunger body 7140 and small magnetic part 7162 to ensure proper movement of the displacement member. End caps 7130 and 7160 hold bobbin 7195 and coil 7148 in place.
此外，安装板可用于捕获和保持端帽7130。在一个实施方案中，安装板定位成竖直地并且紧贴端帽的侧齐平并且在端帽和钻孔之间。安装板具有在其中的孔，近似地与端帽的较小直径相同的尺寸。夹持机构将主体保持为紧贴该板；可选地，所述板可以通过使用任何本领域技术人员已知的结合技术而被永久地固定。与现有技术例如美国专利第683620l号不同，在一个优选的实施方案中，磁体定位在钻孔内侧而不是外侧，并且提供用于柱塞的轴承，如下文讨论。Additionally, a mounting plate can be used to capture and hold the end cap 7130. In one embodiment, the mounting plate is positioned vertically and flush against the side of the end cap and between the end cap and the bore. The mounting plate has a hole therein approximately the same size as the smaller diameter of the end cap. A clamping mechanism holds the body against the plate; alternatively, the plate may be permanently secured using any bonding technique known to those skilled in the art. Unlike prior art such as US Patent No. 6836201, in a preferred embodiment the magnet is positioned inside the borehole rather than outside and a bearing for the plunger is provided, as discussed below.
大磁体部件7132通过缝隙7197和弹性材料7134例如硅树脂垫片与芯部7142分隔，在一个实施方案中，该硅树脂垫片具有0.3至0.5英寸(并且更特别地0.37英寸)的外径、0.1至0.3英寸(并且更特别地0.188英寸)的内径、0.005至0.015英寸(并且更特别地0.0l英寸)的厚度、以及35至45(并且更特别地40)的硬度。小磁体部件7162通过弹性材料7164例如硅树脂垫片与芯部分隔，在一个实施方案中，该硅树脂垫片具有0.1至0.4英寸(并且更特别地0.24英寸)的外径、0.1至0.3英寸(并且更特别地0.188英寸)的内径、0.005至0.015英寸(并且更特别地0.0l英寸)的厚度、以及35至45(并且更特别地40)的硬度。小磁性部件7162被小磁体安装部和端帽7160支承并保持为在外壳7170内适当对准。小磁体端帽螺钉7172也用于捕获和将小磁体端帽7160保持就位。The large magnet component 7132 is separated from the core 7142 by a gap 7197 and a resilient material 7134, such as a silicone spacer, which in one embodiment has an outer diameter of 0.3 to 0.5 inches (and more specifically 0.37 inches), An inner diameter of 0.1 to 0.3 inches (and more specifically 0.188 inches), a thickness of 0.005 to 0.015 inches (and more specifically 0.01 inches), and a durometer of 35 to 45 (and more specifically 40). The small magnet component 7162 is separated from the core by a resilient material 7164, such as a silicone spacer, which in one embodiment has an outer diameter of 0.1 to 0.4 inches (and more specifically 0.24 inches), 0.1 to 0.3 inches (and more specifically 0.188 inches), a thickness of 0.005 to 0.015 inches (and more specifically 0.01 inches), and a durometer of 35 to 45 (and more specifically 40). The small magnetic component 7162 is supported and held in proper alignment within the housing 7170 by the small magnet mount and end cap 7160 . The small magnet end cap screw 7172 is also used to capture and hold the small magnet end cap 7160 in place.
参照图7lA，本发明的阀系统还包括线圈驱动器回路板7150、线圈驱动器连接器7154和光学传感器7152，该线圈驱动器回路板驱动包括线圈7148的致动器，并且优选地经由小螺钉安装至致动器主体7170，该光学传感器感测芯部7196的大端部的位置。线圈7148用于导致磁场的改变，以使芯部7142和柱塞体7140产生运动。在一个实施方案中，线圈是约0.05至1.5英寸长(并且更特别地l英寸长)，具有0.35至0.55英寸(并且更特别地0.46英寸)的外径，以及0.15至0.35英寸(并且更特别地0.26英寸)的内径，具有六层的线29AWG线。Referring to FIG. 71A, the valve system of the present invention also includes a coil driver circuit board 7150, a coil driver connector 7154, and an optical sensor 7152. The coil driver circuit board drives the actuator including the coil 7148 and is preferably mounted to the actuator via small screws. The actuator body 7170, the optical sensor senses the position of the large end of the core 7196. Coil 7148 is used to cause a change in the magnetic field to cause motion of core 7142 and plunger body 7140 . In one embodiment, the coil is about 0.05 to 1.5 inches long (and more specifically 1 inch long), has an outer diameter of 0.35 to 0.55 inches (and more specifically 0.46 inches), and 0.15 to 0.35 inches (and more specifically ground 0.26 inches) inside diameter, with six layers of wire 29AWG wire.
在位移构件和用于运动位移构件的机构中使用的各种弹性材料提供当阀打开或关闭时的对杆7140运动的“软”停止。特别地，其用于确保芯部的运动不破坏磁体。Various elastic materials used in the displacement member and the mechanism for moving the displacement member provide a "soft" stop to the movement of the rod 7140 when the valve is opened or closed. In particular, it serves to ensure that movement of the core does not damage the magnet.
大磁体部件7132可以是一个单一磁体，或者在一个优选的实施方案中，包括多个磁体，例如三个。小磁体部件7162也可以是单一磁体或包括多个磁体。在一个实施方案中，磁体优选地由磁钢、钐钴、钕、稀土或陶瓷磁体制成。在一个实施方案中，大磁体7132是钕环形磁体，具有0.2至0.5英寸(并且更特别地0.375英寸)的外径、0.05至0.3英寸(并且更特别地0.125英寸)的内径、以及0.2至0.5英寸(并且更特别地0.375英寸)的长度。在一个实施方案中，小磁体7162由钕环形磁体制成，具有0.15至0.4英寸(并且更特别地0.25英寸)的外径、0.05至0.3英寸(并且更特别地0.125英寸)的内径、和0.15至0.4英寸(并且更特别地0.25英寸)的长度。较大的磁体7132用于更靠近孔口关闭构件，因为该尺寸是产生足够的与阀座相反的力所必须的。此外，由致动线圈产生的致动力大致相等，即使磁体具有不同的尺寸，从而导致简单的线圈驱动器回路。The large magnet assembly 7132 can be a single magnet, or in a preferred embodiment, include multiple magnets, such as three. Small magnet assembly 7162 can also be a single magnet or include multiple magnets. In one embodiment, the magnets are preferably made of magnet steel, samarium cobalt, neodymium, rare earth or ceramic magnets. In one embodiment, the large magnet 7132 is a neodymium ring magnet having an outer diameter of 0.2 to 0.5 inches (and more specifically 0.375 inches), an inner diameter of 0.05 to 0.3 inches (and more specifically 0.125 inches), and a diameter of 0.2 to 0.5 inches. inches (and more particularly 0.375 inches) in length. In one embodiment, the small magnets 7162 are made of neodymium ring magnets with an outer diameter of 0.15 to 0.4 inches (and more specifically 0.25 inches), an inner diameter of 0.05 to 0.3 inches (and more specifically 0.125 inches), and 0.15 inches. to 0.4 inches (and more particularly 0.25 inches) in length. A larger magnet 7132 is used closer to the orifice closure member, as this size is necessary to generate sufficient force against the valve seat. Furthermore, the actuation forces generated by the actuation coils are approximately equal even though the magnets are of different sizes, resulting in a simple coil driver circuit.
在一个实施方案中，杆、柱塞或其他细长构件7140使用磁体的中心孔作为线性支承。因此，磁体的中心孔应当优选地具有支承表面，例如铬或任何具有最小摩擦的平滑硬表面。缝隙设置在绕线管7195和芯部7142之间，因为存在绕线管的热膨胀、随时间变化的绕线管蠕变、以及绕线管、芯部和磁体公差。然而，在所有的操作条件下，缝隙应当是足够的，使得柱塞体7140可以自由地运动并且不结合在磁体和线圈的开口中。在一个优选的实施方案中，缝隙在室温约为0.01至0.06英寸(并且更特别地0.02英寸)。In one embodiment, the rod, plunger or other elongated member 7140 uses the center hole of the magnet as a linear support. Therefore, the central bore of the magnet should preferably have a bearing surface such as chrome or any smooth hard surface with minimal friction. A gap is provided between bobbin 7195 and core 7142 because of thermal expansion of the bobbin, bobbin creep over time, and bobbin, core, and magnet tolerances. However, under all operating conditions, the gap should be sufficient so that the plunger body 7140 can move freely and not bind in the magnet and coil openings. In a preferred embodiment, the gap is about 0.01 to 0.06 inches (and more specifically 0.02 inches) at room temperature.
参照图7lB，当阀关闭时，本发明的阀系统7l00通过压缩孔口关闭构件例如膜片7106并且从而阻碍阀环形孔口7103来控制通过由阀座7104约束的流体流动通道7102的流体流动。在关闭状态中，膜片7106的主体压靠着阀座7104，因此基本上消除缝隙7198(在图7lA中所见)。Referring to FIG. 71B, the valve system 7100 of the present invention controls fluid flow through a fluid flow channel 7102 constrained by a valve seat 7104 by compressing an orifice closing member such as a diaphragm 7106 and thereby obstructing the valve annular orifice 7103 when the valve is closed. In the closed state, the main body of the diaphragm 7106 is pressed against the valve seat 7104, thus substantially eliminating the gap 7198 (seen in Figure 71A).
一旦紧邻膜片7106，则位移构件现在就压缩膜片7106。特别地，柱塞帽7110已经运动成压缩膜片7106。柱塞帽7110已经运动，因为磁场的改变使芯部体7142朝向大磁体部件7132运动。当芯部头部7196穿过缝隙7197时(在图7lA中)芯部体7142停止运动，并且在定位成毗邻于大磁体部件7132的弹性材料7134处停止。芯部7142的运动使芯部7142所结合的柱塞体7140也运动。柱塞体7140的运动使柱塞头7199在柱塞帽7110内运动，穿过缝隙7114(在图7lA中)，并且压缩弹簧7112。在一定量的压缩之后，柱塞帽7110运动并且压缩膜片7106。柱塞帽7110的运动在帽主体7110和定位成毗邻于大磁体端帽7130的弹性材料7120之间产生新的缝隙7192。Once in close proximity to the diaphragm 7106, the displacement member now compresses the diaphragm 7106. In particular, plunger cap 7110 has been moved to compress diaphragm 7106 . The plunger cap 7110 has moved because the change in the magnetic field moves the core body 7142 towards the large magnet part 7132. Core body 7142 stops moving when core head 7196 passes through gap 7197 (in FIG. 71A ), and stops at resilient material 7134 positioned adjacent to large magnet member 7132. Movement of the core 7142 moves the plunger body 7140 to which the core 7142 is coupled. Movement of the plunger body 7140 moves the plunger head 7199 within the plunger cap 7110, through the gap 7114 (in FIG. 71A ), and compresses the spring 7112. After a certain amount of compression, the plunger cap 7110 moves and compresses the diaphragm 7106. Movement of the plunger cap 7110 creates a new gap 7192 between the cap body 7110 and the resilient material 7120 positioned adjacent to the large magnet end cap 7130 .
如图7lB所示，阀的其他部件保持相同，包括致动器主体7170、线圈驱动器回路7150、线圈连接器7154、线圈7148、绕线管7193、小端帽螺钉7172、光学传感器7152和小磁体端帽7160。然而，应当理解的是，借助于芯部7142运动，缝隙7195在芯部7194的较小端部和弹性材料7164之间产生，该弹性材料定位成毗邻于小磁性部件7162。As shown in Figure 71B, the other parts of the valve remain the same, including the actuator body 7170, coil driver circuit 7150, coil connector 7154, coil 7148, bobbin 7193, small end cap screw 7172, optical sensor 7152 and small magnet End Cap 7160. However, it should be understood that by virtue of the movement of the core 7142 , a gap 7195 is created between the smaller end of the core 7194 and the resilient material 7164 positioned adjacent the small magnetic member 7162 .
应当理解的是，为了关闭阀，位移构件将力施加到孔口关闭构件，例如膜片7106。来自位移构件的为了将膜片变形至膜片接触阀座的点所需的力是大致线性的，并且可以被建模为线性弹簧。然而，随着膜片被压缩到阀座中，力需求呈指数增加。因此，用于位移构件的力曲线成为非线性的并且更加复杂。因此，具有与阀的设计和在位移构件的各个部件、孔口关闭构件以及位移机构的硬停止部之间的公差相关的某些独特挑战。位移机构必须能够递送非线性力曲线，而不永久地变形膜片。这意味着机构必须递送正好适量的力。It should be understood that in order to close the valve, the displacement member applies a force to the orifice closing member, such as diaphragm 7106 . The force required from the displacement member to deform the diaphragm to the point where the diaphragm contacts the valve seat is approximately linear and can be modeled as a linear spring. However, as the diaphragm is compressed into the seat, the force requirement increases exponentially. Consequently, the force curve for the displacement member becomes non-linear and more complex. Accordingly, there are certain unique challenges associated with the design of the valve and the tolerances between the various components of the displacement member, the orifice closing member, and the hard stops of the displacement mechanism. The displacement mechanism must be able to deliver a non-linear force profile without permanently deforming the diaphragm. This means that the mechanism must deliver just the right amount of force.
如上文讨论，位移构件包括结合到被称为芯部的另一个结构的杆、柱塞或其他细长构件，该芯部具有更大的直径并且可以在被向上紧贴另一个结构例如磁体面时用作停止器。本领域技术人员应当理解的是，位移构件或可运动构件不限于杆和圆筒配置。相反，其可以包括非圆柱形结构、单一件、或者被焊接或以任何其他方式结合在一起的多个部件。总之，位移构件可以包括许多不同的结构，只要构件的运动可以将必需的力施加在孔口上，以可靠且一致的方式压缩构件。As discussed above, the displacement member comprises a rod, plunger or other elongated member bonded to another structure called a core, which has a larger diameter and can be pressed against another structure such as a magnet face upwards. when used as a stopper. Those skilled in the art will appreciate that the displacement member or movable member is not limited to a rod and cylinder configuration. Rather, it may comprise a non-cylindrical structure, a single piece, or multiple components that are welded or joined together in any other way. In summary, the displacement member can comprise many different configurations as long as the movement of the member can exert the necessary force on the orifice to compress the member in a reliable and consistent manner.
例如，参照图73，示出了可选择的较不优选的实施方案。对于肾脏透析应用来说，本实施方案并不通常可靠地将阀保持在关闭状态。位移构件7300包括外壳7305，其包括具有大致圆柱形结构的电磁体7310和延伸穿过其的钻孔7315。电磁体7310由非磁性间隔器7320牢固地居中定位在外壳7305内，在一个实施方案中，该非磁性间隔器是端帽。端帽具有两个目的—将磁体保持就位和将线圈夹住就位。在一个实施方案中，元件733l和7320包括第一一体件，7305和7320包括第二一体件。具有第一面7323和第二面7324的圆柱形形状的铁磁芯部7325定位成允许芯部7325在第一面7323和第二面7324之间的一部分具有与钻孔7315的线性可滑动装配。第二面7324足够地比钻孔7315更大，从而限制芯部7325的线性运动。在一个实施方案中，第二面相对于第一面被不同地确定大小，以产生足够的磁力来将阀保持在关闭位置。芯部7325能够在钻孔7315内进行左右线性滑动运动。For example, referring to Fig. 73, an alternative less preferred embodiment is shown. For kidney dialysis applications, this embodiment does not usually reliably hold the valve closed. The displacement member 7300 includes a housing 7305 that includes an electromagnet 7310 having a generally cylindrical configuration and a bore 7315 extending therethrough. The electromagnet 7310 is securely centered within the housing 7305 by a non-magnetic spacer 7320, which in one embodiment is an end cap. The end caps serve two purposes - holding the magnet in place and clamping the coil in place. In one embodiment, elements 7331 and 7320 comprise a first integral piece and elements 7305 and 7320 comprise a second integral piece. A ferromagnetic core portion 7325 of cylindrical shape having a first face 7323 and a second face 7324 is positioned to allow a portion of the core portion 7325 between the first face 7323 and the second face 7324 to have a linearly slidable fit with the bore 7315 . The second face 7324 is sufficiently larger than the bore 7315 so that the linear movement of the core 7325 is restricted. In one embodiment, the second face is sized differently relative to the first face to generate sufficient magnetic force to hold the valve in the closed position. The core 7325 is capable of linear sliding movement left and right within the bore 7315 .
两个不同尺寸的磁体7330、7335也被固定在外壳7305内并且被固定在该外壳的两个端帽733l、7332处。芯部7325的第一面7323与第一磁体7330接触以形成位移系统7300的第一稳定状态，并且芯部7325的第二面7324与较大的磁体7335接触以形成位移系统7300的第二稳定状态。永磁体7330、7335的放置设计成在外壳7305的直径内，因为其减少位移系统7300的尺寸。连接到芯部7325的第一面7323的第一杆7340穿过第一磁体7330，从而在一个端部从外壳7305突出，并且连接到芯部7325的第二面7324的第二杆7345穿过第二磁体7335，从而在另一个端部从外壳7305突出。杆7340、7345可以由本领域中已知的非腐蚀性的非磁性材料例如但不限于黄铜制成。虽然一个实施方案具有连接到芯部的两个面的两个杆，但是在一个可选择的实施方案中，具有连接到梭的面之一的唯一的一个杆。Two different sized magnets 7330, 7335 are also secured within the housing 7305 and at two end caps 7331, 7332 of the housing. The first face 7323 of the core 7325 is in contact with the first magnet 7330 to form a first stable state of the displacement system 7300, and the second face 7324 of the core 7325 is in contact with the larger magnet 7335 to form a second stable state of the displacement system 7300 state. The placement of the permanent magnets 7330, 7335 is designed to be within the diameter of the housing 7305 as it reduces the size of the displacement system 7300. A first rod 7340 connected to the first face 7323 of the core 7325 passes through the first magnet 7330 so as to protrude from the housing 7305 at one end, and a second rod 7345 connected to the second face 7324 of the core 7325 passes through The second magnet 7335 thus protrudes from the housing 7305 at the other end. The rods 7340, 7345 may be made of non-corrosive, non-magnetic materials known in the art such as, but not limited to, brass. While one embodiment has two rods connected to both faces of the core, in an alternative embodiment there is only one rod connected to one of the faces of the shuttle.
本领域技术人员要理解的是，由电磁体7310施加在芯部7325上的磁力高至足以克服永磁体7330、7335的保持力，使得位移系统7300可以从第一稳定状态改变至第二稳定状态。此外，本领域技术人员要理解的是，杆/柱塞7345随着芯部7325运动，从而产生起动力来压缩或解压缩孔口关闭构件。然而，本实施方案已经确定为劣于第一实施方案，因为其不能充分地保持关闭状态。Those skilled in the art will appreciate that the magnetic force exerted by the electromagnet 7310 on the core 7325 is high enough to overcome the holding force of the permanent magnets 7330, 7335 such that the displacement system 7300 can change from a first stable state to a second stable state . Furthermore, it will be appreciated by those skilled in the art that the rod/plunger 7345 moves with the core 7325, thereby creating a motive force to compress or decompress the orifice closure member. However, this embodiment has been determined to be inferior to the first embodiment in that it cannot adequately remain closed.
与位移构件和机构共同操作的孔口关闭构件的某些设计特征应当被理解。第一，参照图74，并且如上文参照图7lA和7lB所讨论，缝隙7408存在于柱塞帽7404和孔口关闭构件7405(特别是第一膜片面7405)之间。缝隙7408在0.040至0.070英寸的范围内并且更特别地约0.055英寸。膜片包含硅树脂，优选地具有0.040英寸的厚度，并且可以被建模为具有2701bf/in的弹簧常数的弹簧(KV2)。第二膜片面7406与阀座7407分隔并且被建模为具有约22.51bf/in的弹簧常数和约0.047英寸厚度的弹簧KV1的磁力作用。Certain design features of the orifice closure member co-operating with the displacement member and mechanism should be understood. First, referring to FIG. 74 , and as discussed above with reference to FIGS. 71A and 71B , a gap 7408 exists between the plunger cap 7404 and the orifice closing member 7405 (specifically, the first diaphragm face 7405 ). The gap 7408 is in the range of 0.040 to 0.070 inches and more specifically about 0.055 inches. The diaphragm is comprised of silicone, preferably has a thickness of 0.040 inches, and can be modeled as a spring (KV2 ) with a spring constant of 270 lbf/in. The second diaphragm face 7406 is spaced from the valve seat 7407 and is modeled as the magnetic action of a spring KV1 with a spring constant of about 22.51 bf/in and a thickness of about 0.047 inches.
杆7404将由芯部740l的磁吸引产生的力过渡至由弹簧KP建模的磁体7403，该弹簧在关闭状态中被垫片例如0.010英寸的硅树脂与芯部头部7401分隔，并且在开放状态中与芯部头部7401分隔约0.110英寸。该硅树脂垫片提供被建模为弹簧KSL的力。芯部740l被结合到杆7404。当阀被致动时，杆7404在阀座7407的方向上运动，因为杆所结合的芯部在大磁体7403的方向上运动。The rod 7404 transitions the force generated by the magnetic attraction of the core 7401 to the magnet7403 modeled by a spring KP that is separated from the core head 7401 by a spacer such as 0.010 inches of silicone in the closed state and in the open state. The state is separated from the core head 7401 by about 0.110 inches. The silicone spacer provides a force modeled as a spring KSL . Core 7401 is bonded to rod 7404 . When the valve is actuated, the rod 7404 moves in the direction of the valve seat 7407 because the core to which the rod is attached moves in the direction of the large magnet 7403 .
参照图74，KV2和KSL对应于被建模为刚性弹簧的弹性材料，例如硅树脂。应当理解的是，当阀处于关闭状态时，具有两个重要的位置。第一个是杆紧贴膜片的位置，第二个是芯部面紧贴大磁体的位置。当阀被关闭时，杆正在使用足够的力压在阀膜片上，以抵抗在肾脏透析系统的流体通路内产生的至少600mmHg背压。在本实施方案中，流体压力可以达到2600mmHg并且该系统7400被设计为将膜片保持为牢固地紧贴阀座以密封孔口高至并且包括2600mmHg。Referring to Figure 74, KV2 and KSL correspond to elastic materials, such as silicone, that are modeled as rigid springs. It should be understood that when the valve is in the closed state, there are two important positions. The first is where the rod is against the diaphragm and the second is where the core face is against the large magnet. When the valve is closed, the stem is pressing against the valve diaphragm with sufficient force to resist a back pressure of at least 600mmHg developed within the fluid pathway of the kidney dialysis system. In this embodiment, fluid pressure can reach 2600mmHg and the system 7400 is designed to hold the diaphragm firmly against the valve seat to seal the orifice up to and including 2600mmHg.
此外，当阀被关闭时，芯部的大面被拉动接近于或直接紧贴大磁体。芯部的至大磁体的磁吸引产生杆施加于孔口关闭构件例如膜片的力。为了产生一致且可靠的力，芯部面和大磁体的面之间的间距必须一致。因此，优选的是，将弹性材料7402放置在芯部面740l和磁体面7404之间。弹性材料具有非线性的弹簧常数，并且将压缩，直到用于弹性材料的合力等于磁力。当杆将力经由芯部施加到膜片时，芯部将经历该合力。对于要发生的静态条件来说，芯部上的这些力的和必须等于零。此外，弹性材料用于保护磁体面不在致动期间剥落或断裂。Furthermore, when the valve is closed, the large face of the core is drawn close to or directly against the large magnet. The magnetic attraction of the core to the large magnet generates the force that the rod exerts on the orifice closing member, eg the diaphragm. In order to generate consistent and reliable force, the spacing between the face of the core and the face of the large magnet must be consistent. Therefore, it is preferred to place the elastic material 7402 between the core face 7401 and the magnet face 7404 . An elastic material has a non-linear spring constant and will compress until the resultant force applied to the elastic material equals the magnetic force. When the rod applies a force to the diaphragm via the core, the core will experience this resultant force. For static conditions to occur, the sum of these forces on the core must equal zero. Additionally, a resilient material is used to protect the magnet face from peeling or breaking during actuation.
参照图76，当阀7600处于关闭状态时，芯部头部7605、7602已经运动远离小磁体面760l(从位置7602a至位置7602)。当在位置7602中时，芯部头部被弹性材料7617例如具有约0.015英寸厚度的硅树脂垫片与小磁体7601分隔。当在位置7605时，芯部头部将已经运动约0.140+/-0.20英寸，包括0.45+/-0.005英寸的距离，杆7608在这期间不运动，并且紧贴弹性材料7616(例如具有约0.015英寸厚度的硅树脂垫片)停止，该弹性材料将芯部头部7605与大磁体面7606分隔。大磁体7606进而与杆头部7607分隔。Referring to Figure 76, when the valve 7600 is in the closed state, the core head 7605, 7602 has moved away from the small magnet face 7601 (from position 7602a to position 7602). When in position 7602, the core head is separated from the small magnet 7601 by a resilient material 7617, such as a silicone spacer having a thickness of about 0.015 inches. When in position 7605, the core head will have moved about 0.140+/-0.20 inches, including a distance of 0.45+/-0.005 inches, during which time the rod 7608 has not moved, and is against the elastic material 7616 (e.g., with about 0.015 inches inches thick silicone spacer), the elastic material that separates the core head 7605 from the large magnet face 7606. The large magnet 7606 is in turn spaced from the club head 7607.
当阀处于开放状态时，大磁体7606被弹性材料7615例如具有约0.015英寸厚度的硅树脂垫片与杆头部7607分隔。当阀处于关闭状态时，大磁体7606被弹性材料7615例如具有约0.015英寸厚度的硅树脂垫片与杆头部7607分隔并且分隔约0.055+/-0.10英寸的距离。当阀被关闭时，杆头部7607已经从紧邻于大磁体7606和弹性材料7615运动至紧邻于阀座7610。特别地，杆头部7607运动来压缩膜片7608，从而压靠着弹性材料7609(例如具有约0.040英寸厚度的硅树脂)，该弹性材料进而又压靠着阀座7610。这促使采用约14N的力来关闭阀。When the valve is in the open state, the large magnet 7606 is separated from the rod head 7607 by a resilient material 7615, such as a silicone spacer having a thickness of about 0.015 inches. When the valve is in the closed state, the large magnet 7606 is separated from the stem head 7607 by a resilient material 7615, such as a silicone spacer having a thickness of about 0.015 inches, and a distance of about 0.055 +/- 0.10 inches. When the valve is closed, the stem head 7607 has moved from being next to the large magnet 7606 and the resilient material 7615 to being next to the valve seat 7610. In particular, movement of the stem head 7607 compresses the diaphragm 7608 against an elastomeric material 7609 (eg, silicone having a thickness of about 0.040 inches), which in turn presses against the valve seat 7610 . This induces a force of about 14N to close the valve.
应当理解的是，位移构件及机构相对于孔口关闭构件的配置和本文描述公差提供膜片位移曲线7500，如图75所示，该膜片位移曲线适于需要抵抗至少600mmHg背压的应用，例如肾脏透析系统。参照图75，提供了示例性的膜片位移曲线750l，其中由位移构件施加的力7502设置在y轴上，相应的膜片位移设置在x轴上。该曲线7503上的拐点指示膜片何时开始被压缩紧贴阀座。至拐点7503的左侧，膜片正被迫朝向阀座弯曲，但是没有紧贴阀座的实质性压缩。至拐点7503的右侧，膜片紧贴着阀座弯曲，使膜片材料变型并且影响对流体压力的良好密封。It should be understood that the configuration of the displacement member and mechanism relative to the orifice closure member and the tolerances described herein provide a diaphragm displacement curve 7500, as shown in Figure 75, suitable for applications requiring resistance to back pressure of at least 600 mmHg, Such as kidney dialysis system. Referring to FIG. 75 , an exemplary diaphragm displacement curve 7501 is provided wherein a force 7502 exerted by a displacement member is provided on the y-axis and a corresponding diaphragm displacement is provided on the x-axis. The point of inflection on this curve 7503 indicates when the diaphragm begins to be compressed against the valve seat. To the left of inflection point 7503, the diaphragm is being forced to flex towards the seat, but there is no substantial compression against the seat. To the right of inflection point 7503, the diaphragm bends against the valve seat, deforming the diaphragm material and affecting a good seal against fluid pressure.
位移机构系统的另一个重要部件是在图72中描绘的致动器系统7200。在致动过程期间，线圈7205被激励并且磁场构建，因此产生与小磁体吸引力相反的磁力。当力构建时，上文讨论的芯部开始运动至关闭位置(大磁体)。一旦芯部运动经过不可返回点，则大磁体芯部上的吸引力已经克服小磁体的吸引力。为了确保由阀膜片导致的相反力不克服大磁体的吸引力，设置有缝隙，如上文讨论。Another important component of the displacement mechanism system is the actuator system 7200 depicted in FIG. 72 . During the actuation process, the coil 7205 is energized and a magnetic field builds, thus creating a magnetic force that opposes the attractive force of the small magnets. When the force builds, the core discussed above begins to move to the closed position (big magnet). Once the core has moved past the point of no return, the attractive force on the core of the large magnet has overcome the attractive force of the small magnet. To ensure that the opposing force caused by the valve diaphragm does not overcome the attractive force of the large magnet, a gap is provided, as discussed above.
线圈设计由线圈形式和磁线7210制成。线圈形式尺寸的大小优选地基于可商购获得的线圈形式、电源的脉冲电流容量以及特别地所需的致动力和电源电压。致动力与线圈的安培-匝额定成比例。在一个实施方案中，优选的是将线圈电流限制到6安培或更少。The coil design is made from a coil form and magnet wire 7210. The dimensioning of the coil form is preferably based on the commercially available coil form, the pulse current capacity of the power supply and in particular the required actuation force and supply voltage. The actuation force is proportional to the ampere-turn rating of the coil. In one embodiment, it is preferred to limit the coil current to 6 amps or less.
线圈设计中的重要因素包括层的数量、装填系数、线直径和线圈电阻。在一个实施方案中，本发明使用的绕线管具有6层线并且在绕线管凸缘直径和最后一层之间的空间约为0.010英寸。采用重聚合尼龙的绝缘要求和3.5+/-0.5欧姆的线圈电阻，线尺寸是约29AWG。可以使用任何尺寸的线圈形式。Important factors in coil design include the number of layers, packing factor, wire diameter, and coil resistance. In one embodiment, the bobbin used with the present invention has 6 layers of wire and the space between the diameter of the bobbin flange and the last layer is about 0.010 inches. With the insulation requirements of heavy polymerized nylon and a coil resistance of 3.5+/-0.5 ohms, the wire size is about 29AWG. Coil forms of any size can be used.
用于驱动线圈的电路是H桥接电路，其使电流能够为了打开和关闭操作而被反转。H桥接电路通过独特的脉冲宽度调制(PWM)信号被驱动。PWM信号用于产生通过线圈的余弦电流脉冲。余弦脉冲的周期与芯部质量和相反力有关。优选的实施方案不使用双极DC功率开关或传感开关；相反，光学传感器操作来确定芯部的位置，推断阀状态，并且产生电子驱动余弦波形以使柱塞在期望的方向上运动，从而改变阀的状态。The circuit used to drive the coils is an H bridge circuit which enables the current to be reversed for opening and closing operations. The H-bridge circuit is driven by a unique pulse width modulation (PWM) signal. A PWM signal is used to generate a cosine current pulse through the coil. The period of the cosine pulse is related to the mass of the core and the opposing force. The preferred embodiment does not use a bipolar DC power switch or a sense switch; instead, an optical sensor operates to determine the position of the core, infer the valve state, and generate an electronic drive cosine waveform to move the plunger in the desired direction, thereby Change the state of the valve.
可选地，如图7lA和7lB所示，阀系统7l00使用作为元件7152的传感器，优选的是光学传感器7152，以确定阀的状态(打开或关闭)。这可以通过将光学传感器7152定位在具有在阀打开状态和阀关闭状态之间的反射性或其他光学性质上的足够差异的位置中来实现。例如，当阀被关闭时，在一个实施方案中，芯部7196的大端部定位成紧贴弹性材料7134和大磁体部件7132。芯部7196的大端部具有足够宽的宽度，以被反射性光学传感器7152感测到，但是不过于宽，所以光学传感器7152具有位置分辨率。光学传感器7l52将被放置在位移构件/机构的外侧并且通过其主体进行观测，该主体优选地由透明的聚碳酸酯制成。光学传感器7152的波长将在接近红外范围(NIR)内，以便具有穿过聚碳酸酯主体的良好透射。本领域技术人员要理解的是，传感器可被选择来适合任何材料结构，只要其包括合适的滤波器。在本文中，光学传感器7152优选地具有内置到其中的用于NIR响应的长通滤光器。Optionally, as shown in Figures 71A and 71B, the valve system 7100 uses a sensor, preferably an optical sensor 7152, as element 7152, to determine the state of the valve (open or closed). This can be achieved by positioning the optical sensor 7152 in a location that has a sufficient difference in reflectivity or other optical properties between the valve open state and the valve closed state. For example, when the valve is closed, in one embodiment, the large end of the core 7196 is positioned against the elastic material 7134 and the large magnet member 7132 . The large end of the core 7196 has a width wide enough to be sensed by the reflective optical sensor 7152, but not too wide so the optical sensor 7152 has positional resolution. The optical sensor 7152 will be placed on the outside of the displacement member/mechanism and view through its body, which is preferably made of clear polycarbonate. The wavelength of the optical sensor 7152 will be in the near infrared range (NIR) in order to have good transmission through the polycarbonate body. It will be understood by those skilled in the art that the sensor may be selected to suit any material structure as long as it includes appropriate filters. Herein, the optical sensor 7152 preferably has a long pass filter built into it for NIR response.
在功能上，当芯部处于开放位置时，如图7lA所示，芯部7196的大端部移出光学传感器7152的视野，因止几乎没有反射将被光学传感器看到。当芯部7196的大端部在视野中时，如图7lB所示，将具有传感器7152将看到的反射，从而指示芯部处于关闭位置。本领域技术人员要理解的是，传感器7152可以定位成使得当阀7l00处于开放位置时其感测来自芯部的大量反射，并且当阀7l00处于关闭位置时其感测更少的反射(因为芯部移出了视野)。此外，本领域技术人员要理解的是，传感器7152可以定位成紧邻于缝隙来感测缝隙何时存在以及缝隙何时不存在，从而指示阀7l00的状态。Functionally, when the core is in the open position, as shown in FIG. 71A, the large end of the core 7196 is moved out of the field of view of the optical sensor 7152, so almost no reflections will be seen by the optical sensor. When the large end of the core 7196 is in view, as shown in Figure 71B, there will be a reflection that the sensor 7152 will see, indicating that the core is in the closed position. Those skilled in the art will understand that the sensor 7152 can be positioned such that it senses a large amount of reflection from the core when the valve 7100 is in the open position, and it senses fewer reflections when the valve 7100 is in the closed position (because the core out of view). Additionally, it will be appreciated by those skilled in the art that sensor 7152 may be positioned proximate to the slit to sense when a slit is present and when it is not, thereby indicating the status of valve 7100.
虽然上述实施方案中的歧管膜片的大致平面表面导致功能系统，但这种系统的响应被延迟。具体地，透析机中的传感器或销与膜片表面之间的缝隙或死空间产生见于图75的响应曲线。当膜片开始压靠着阀座时，直到拐点7503才看见响应。然而，在某些实施方案中，更直接的响应性可能是期望的。因此，在其他实施方案中，歧管包括一个或多个膜片，其中在其外表面上的凸起的部分或突出部配置成与透析机销或传感器充分地紧密接触，使得存在于上述实施方案中的缝隙得以消除。消除缝隙或死空间导致系统响应于销运动到膜片中的改进的线性度。While the generally planar surface of the manifold diaphragm in the above embodiments results in a functional system, the response of such a system is delayed. Specifically, the gap or dead space between the sensor or pin and the surface of the diaphragm in the dialysis machine produces the response curve seen in FIG. 75 . No response is seen until inflection point 7503 when the diaphragm begins to press against the valve seat. However, in certain embodiments, more immediate responsiveness may be desired. Thus, in other embodiments, the manifold includes one or more diaphragms with raised portions or protrusions on its outer surface configured to make sufficiently intimate contact with the dialysis machine pins or sensors that the presence of the above described embodiments Gaps in the scheme are eliminated. Elimination of the gap or dead space results in improved linearity of the system in response to pin movement into the diaphragm.
图71C是带有凸起的凸表面7120的歧管膜片7106的一个实施方案的剖视图。膜片7106的表面7120开始于歧管7107的相同水平，相对于歧管7107的高度在其长度l上增加并且然后减少高度h。在一个实施方案中，膜片的长度l测量约为0.625英寸至0.675英寸。在一个实施方案中，在中间的相对于歧管7107的外表面的高度h总增加介于0.03和0.04英寸之间。在一个实施方案中，膜片的厚度t在其整个长度l上相对恒定，测量在0.03和0.04英寸之间。凸膜将所被希望成在换能器接触膜片的表面时将泡挤压出。然而，创建和维持凸膜结构对于因所产生的热来制造具有挑战性。71C is a cross-sectional view of one embodiment of a manifold membrane 7106 with a raised convex surface 7120. The surface 7120 of the diaphragm 7106 starts at the same level as the manifold 7107, increases in height relative to the manifold 7107 over its length l and then decreases in height h. In one embodiment, the length l of the diaphragm measures from about 0.625 inches to about 0.675 inches. In one embodiment, the height h total increase in the middle relative to the outer surface of the manifold 7107 is between 0.03 and 0.04 inches. In one embodiment, the thickness t of the membrane is relatively constant throughout its length l, measuring between 0.03 and 0.04 inches. The convex membrane would be expected to squeeze the bubble out when the transducer contacts the surface of the membrane. However, creating and maintaining convex membrane structures is challenging to fabricate due to the heat generated.
在大致平坦膜片表面内的小圆顶或突出部更加耐热并且更容易制造。图71D是在大致平面周边7125内具有位于中心的凸起的凸突出部7128的歧管膜片7106的一个实施方案的剖视图。膜片7106的周边7125具有的表面高度与周围歧管7107外表面的高度大致水平。凸起的突出部7128在膜片7106的中心或其周围，在高度上相对于大致平坦周边7125具有明显的阶梯增加。突出部7128具有设计成接触销或传感器的凸表面7120。在一个实施方案中，膜片的总长度l测量约为0.625英寸至0.675英寸。突出部的长度l1测量介于0.125和0.15英寸之间，其在压力换能器的感测直径内，在一个实施方案中，该感测直径是0.185英寸。周边l2在突出部每侧上的长度测量介于0.25和0.2625英寸之间。在一个实施方案中，突出部的总高度h介于0.03和0.04英寸之间。高度的增加由突出部的弯曲表面封端。在一个实施方案中，膜片的厚度t在其整个长度l上相对恒定，并且测量介于0.03和0.04英寸之间。在一个实施方案中，凸起的突出部7128表示总膜片表面的10％至40％，优选的是19％至23％。Small domes or protrusions within the generally flat diaphragm surface are more heat resistant and easier to manufacture. FIG. 71D is a cross-sectional view of one embodiment of a manifold membrane 7106 with a centrally located raised male protrusion 7128 within a generally planar perimeter 7125 . The perimeter 7125 of the diaphragm 7106 has a surface height that is approximately level with the height of the outer surface of the surrounding manifold 7107. The raised protrusion 7128 has a distinct step increase in height relative to the generally flat perimeter 7125 at or around the center of the diaphragm 7106 . The protrusion 7128 has a convex surface 7120 designed to contact a pin or sensor. In one embodiment, the overall length l of the membrane measures from about 0.625 inches to about 0.675 inches. The length11 of the protrusion measures between 0.125 and 0.15 inches, which is within the sensing diameter of the pressure transducer, which in one embodiment is 0.185 inches. The perimeter12 measures between 0.25 and 0.2625 inches in length on each side of the protrusion. In one embodiment, the overall height h of the protrusions is between 0.03 and 0.04 inches. The increase in height is terminated by the curved surface of the protrusion. In one embodiment, the thickness t of the membrane is relatively constant throughout its length l and measures between 0.03 and 0.04 inches. In one embodiment, the raised protrusion 7128 represents 10% to 40% of the total diaphragm surface, preferably 19% to 23%.
在另一个实施方案中，膜片的周边和凸起的突出部都具有凸表面，但是具有相对于歧管外表面的不同总高度。图71E是在凸起的凸周边7127内具有位于中心的凸起的凸突出部7128的歧管膜片7106的一个实施方案的剖视图。膜片7106的周边7127具有的表面高度相对于周围歧管7107的大致水平外表面增加。周边7127包括凸表面7123。凸起的突出部7128在膜片7106的中心，在高度上相对于凸周边7127具有明显的阶梯增加。突出部7128具有配置成接触销或传感器的凸表面7120。在一个实施方案中，膜片的总长度l测量约为0.625英寸至0.675英寸。突出部的长度l1测量介于0.125和0.15英寸之间，其在压力换能器的感测直径内，在一个实施方案中，该感测直径是0.185英寸。周边l2在突出部每侧上的长度测量介于0.25和0.2625英寸之间。在一个实施方案中，突出部的总高度h介于0.03和0.04英寸之间。在一个实施方案中，突出部的高度h2在周边的每侧上于限定周边终点和突出部始点的拐点上方测量介于0.10和0.02英寸之间。周边的高度h1在歧管外表面上方测量约为0.02英寸。高度的增加由突出部的弯曲表面封端。在一个实施方案中，膜片的厚度t在其整个长度l上相对恒定，并且测量介于0.03和0.04英寸之间。应该理解的是，在上述各实施方案中，膜片可以具有的厚度在其总长度l上不是恒定的，尽管这不是优选的。In another embodiment, both the perimeter of the diaphragm and the raised protrusion have convex surfaces, but have different overall heights relative to the outer surface of the manifold. FIG. 71E is a cross-sectional view of one embodiment of a manifold membrane 7106 with a centrally located raised convex protrusion 7128 within a raised convex perimeter 7127 . The perimeter 7127 of the diaphragm 7106 has an increased surface height relative to the generally horizontal outer surface of the surrounding manifold 7107. Perimeter 7127 includes convex surface 7123 . The raised protrusion 7128 is at the center of the diaphragm 7106 with a distinct step increase in height relative to the raised perimeter 7127 . The protrusion 7128 has a convex surface 7120 configured to contact a pin or sensor. In one embodiment, the overall length l of the membrane measures from about 0.625 inches to about 0.675 inches. The length11 of the protrusion measures between 0.125 and 0.15 inches, which is within the sensing diameter of the pressure transducer, which in one embodiment is 0.185 inches. The perimeter12 measures between 0.25 and 0.2625 inches in length on each side of the protrusion. In one embodiment, the overall height h of the protrusions is between 0.03 and 0.04 inches. In one embodiment, the height h2 of the protrusion is between 0.10 and 0.02 inches measuredon each side of the perimeter above the inflection point defining the end of the perimeter and the start of the protrusion. The height hiof the perimeter is about 0.02 inches measured above the outer surface of the manifold. The increase in height is terminated by the curved surface of the protrusion. In one embodiment, the thickness t of the membrane is relatively constant throughout its length l and measures between 0.03 and 0.04 inches. It will be appreciated that in the above described embodiments the membrane may have a thickness which is not constant over its total length 1, although this is not preferred.
通过构建整个膜片表面(其可以包括周边和突出部)具有相对恒定的厚度并且包括相对于膜片其余部分具有增加高度的中心区域，压力响应的线性度得到改善。应当理解的是，所公开实施方案的其它变化包括在本说明书内，包括膜片，其中具有大致平坦的周边、在周边的边界内以弯曲方式向上延伸的第一突出部以及在第一突出部内居中的同样在第一突出部的边界内以弯曲方式向上延伸的第二突出部。以这种方式，突出部可以在彼此内分层，以创建从周边朝向膜片中心的在高度上的多个逐步增加。因为许多这样的突出部和阶梯是可能的，并且仅受压力响应的品质和设计的可制造性限制。By constructing the entire diaphragm surface (which may include the perimeter and protrusions) to have a relatively constant thickness and to include a central region of increased height relative to the rest of the diaphragm, the linearity of the pressure response is improved. It should be understood that other variations of the disclosed embodiments are included within this description, including diaphragms having a generally planar perimeter, a first protrusion extending upwardly in a curved manner within the boundary of the perimeter, and within the first protrusion A central second protrusion also extends upwardly in a curved manner within the boundaries of the first protrusion. In this way, the protrusions can be layered within each other to create multiple stepwise increases in height from the periphery towards the center of the diaphragm. Because many such protrusions and steps are possible, and are limited only by the quality of the pressure response and the manufacturability of the design.
操作性地，如参照图77，阀最初处于两个状态之一(打开或关闭)。假设阀处于开放状态770l，则关闭阀的第一个步骤是激励线圈驱动器回路7702，从而使由线圈产生的磁场穿过芯部，在芯部与小磁体之间产生相反的磁力，并且在大磁体与芯部的大端部之间产生弱的吸引力。随着位移构件开始运动7703，小磁体吸引力减小，伴有大磁体吸引力增加。位移构件运动7703直到不可返回点，然后位移构件7704关闭缝隙7704并且压缩孔口关闭构件即膜片7705紧贴阀座7706。膜片7706的压缩使膜片关闭孔口7707并且关闭阀7708。Operationally, as with reference to Figure 77, the valve is initially in one of two states (open or closed). Assuming the valve is in the open state 7701, the first step in closing the valve is to energize the coil driver circuit 7702 so that the magnetic field generated by the coil passes through the core, creating an opposing magnetic force between the core and the small magnet, and at large A weak attractive force is created between the magnet and the large end of the core. As the displacement member begins to move 7703, the attractive force of the small magnet decreases, accompanied by an increase of the attractive force of the large magnet. The displacement member moves 7703 until a point of no return, then the displacement member 7704 closes the gap 7704 and compresses the orifice closing member, diaphragm 7705 against the valve seat 7706 . Compression of the diaphragm 7706 causes the diaphragm to close the orifice 7707 and close the valve 7708 .
假设阀处于关闭状态7709，则打开阀的第一个步骤是激励线圈驱动器回路7710，从而促使由线圈产生的磁场穿过芯部，在芯部与大磁体之间产生相反的磁力，并且在小磁体与芯部的小端部之间产生弱的吸引力。随着位移构件开始运动7711，大磁体吸引力减小，伴有小磁体吸引力增加。位移构件运动7711直到不可返回点，然后位移构件解压缩膜片7712远离阀座7713。孔口借助于不再被膜片7714覆盖而打开。位移构件返回至其初始位置并且再产生缝隙7715，从而返回至打开状态7716。Assuming the valve is in the closed state 7709, the first step in opening the valve is to energize the coil driver circuit 7710, causing the magnetic field generated by the coil to pass through the core, creating an opposing magnetic force between the core and the large magnet, and at the small A weak attractive force is created between the magnet and the small end of the core. As the displacement member begins to move 7711, the attractive force of the large magnet decreases, accompanied by an increase of the attractive force of the small magnet. The displacement member moves 7711 until a point of no return, and then the displacement member decompresses the diaphragm 7712 away from the valve seat 7713. The orifice is opened by being no longer covered by the membrane 7714 . The displacement member returns to its original position and recreates the gap 7715, returning to the open state 7716.
因为即使当给电磁体的功率被切断时芯部的第一和第二稳定状态也被维持，所以位移系统能够具有相对于现有技术致动器的低功率消耗和低热产生，在现有技术致动器中需要连续功率供应来保持状态，此外还导致高热产生。Because the first and second stable states of the core are maintained even when the power to the electromagnet is cut off, the displacement system can have low power consumption and low heat generation relative to prior art actuators, where A continuous power supply is required in the actuator to maintain the state, which in addition results in high heat generation.
盐水反漂洗Brine Back Rinse
参照图86，示出了用于安全高率地进行盐水反漂洗的方法和系统。通常，通过拆卸将透析血液回路在连接部865l处连接到患者的管状节段8658并且将管状节段8658经由连接点8652和8653附接到盐水源8602来进行盐水反漂洗，其用于采用盐水冲洗系统。然而，这种常规的方法具有缺点，包括破坏无菌连接。应当理解的是，连接点可以是任何形式的连接，包括鲁尔连接、搭扣配合、无针插入、阀或任何其他形式的流体连接。Referring to FIG. 86 , a method and system for safe high rate saline back rinsing is shown. Typically, a saline back rinse is performed by detaching the tubular segment 8658 connecting the dialysis blood circuit to the patient at connection 8651 and attaching the tubular segment 8658 to a saline source 8602 via connection points 8652 and 8653, which is used to employ saline Flush the system. However, this conventional approach has disadvantages, including disruption of sterile connections. It should be understood that the connection point may be any form of connection, including a Luer connection, snap fit, needle-free insertion, valve, or any other form of fluid connection.
用于盐水反漂洗的另一个途径包括将盐水源8602经由连接点8652连接到连接点8653，同时保持连接到患者。虽然其避免破坏无菌连接，但是其将患者暴露于可能含有空气泡的盐水流体流动。因为没有空气泡探测器通常存在于盐水连接部8653的点与连接到患者865l的点之间的管状节段8658中，所以具有如下风险：过大的空气泡将形成，并且因为没有用于探测这种空气泡并且告知患者的机构而进入患者的血流，导致实质性损伤。Another approach for a saline back rinse involves connecting a saline source 8602 via connection point 8652 to connection point 8653 while remaining connected to the patient. While it avoids breaking the sterile connection, it exposes the patient to saline fluid flow that may contain air bubbles. Because there is no air bubble detector normally present in the tubular segment 8658 between the point of the saline connection 8653 and the point of connection to the patient 8651, there is a risk that an air bubble that is too large will form and because there is no This air bubble enters the patient's bloodstream and informs the patient's organs, causing substantial damage.
可替代地，用于进行盐水反漂洗的优选途径是保持经由管状节段8658的在患者和透析系统之间的血液回路连接，该管状节段在端口C8605处连接到歧管8600并且在连接点865l连接到患者；并且将盐水源8602在端口D8606处流体地连接到歧管8600。由于患者仍流体地连接到透析系统，所以盐水被允许通过重力或外加压力经由毗邻于端口C8605的端口D8606流入歧管8600。盐水流动用于采用盐水冲洗歧管8600，特别地用于经由端口C8605从歧管8600流出，通过管状节段8658并经由连接部865l进入患者。因为空气泡探测器存在于区8654中，紧邻于端口C8605，所以当歧管8600安装在控制器单元中且因此适于探测在离开端口C8605的流体流动中的空气泡时，离开歧管8600并且朝向患者的盐水将通过区8654中的空气泡探测器被监视空气泡。如果空气泡被探测到，那么警报将响起，从而向患者发出信号：他或她应当从系统断开或者通过使用注射器从进入点8610抽取空气泡。因此，这种用于进行盐水反漂洗的方法和系统保持无菌连接，同时仍监视并且警报空气泡的存在。Alternatively, the preferred route for performing a saline back rinse is to maintain a blood circuit connection between the patient and the dialysis system via tubular section 8658, which is connected to manifold 8600 at port C8605 and at connection point 8651 is connected to the patient; and the saline source 8602 is fluidly connected to the manifold 8600 at port D8606. With the patient still fluidly connected to the dialysis system, saline is allowed to flow into the manifold 8600 via port D8606, which is adjacent to port C8605, by gravity or applied pressure. Saline flow is used to flush the manifold 8600 with saline, specifically to flow out of the manifold 8600 via port C8605, through the tubular segment 8658 and into the patient via connection 8651. Because the air bubble detector exists in zone 8654, next to port C8605, when manifold 8600 is installed in the controller unit and thus adapted to detect air bubbles in the fluid flow leaving port C8605, exit manifold 8600 and Saline towards the patient will be monitored for air bubbles via the air bubble detector in section 8654. If an air bubble is detected, an alarm will sound, signaling to the patient that he or she should disconnect from the system or withdraw the air bubble from the entry point 8610 by using a syringe. Thus, the method and system for performing a saline back rinse maintains a sterile connection while still monitoring and alerting for the presence of air bubbles.
改进的硬件架构Improved hardware architecture
本文公开的透析系统的实施方案还可以包括提供终结系统操作的更快速方法的硬件架构。通常，当警报状态在透析操作期间被遇到时或者如果用户希望终结操作，那么在较高应用层发出的指令必须前进通过多个较低层，以便主动地终结硬件操作。这种构造使用户经受延迟关闭的不必要风险，而延迟关闭在关键应用中是不可接受的。Embodiments of the dialysis systems disclosed herein may also include hardware architectures that provide a faster method of terminating system operations. Typically, when an alarm condition is encountered during a dialysis operation or if the user wishes to terminate the operation, an instruction issued at a higher application layer must proceed through the lower layers in order to actively terminate the hardware operation. This configuration exposes the user to unnecessary risk of delayed shutdown, which is unacceptable in critical applications.
参照图78，透析系统包括至少一个处理器和用于存储在被执行时与软件应用层7805通信的程序指令的存储器。软件应用层7805与主控制器7810接口连接，该主控制器与负责控制各种泵、传感器和阀的多个现场可编程门阵列7815(控制FPGA)数据通信并且与负责监视各种泵、传感器和阀的操作用于超出所接受的操作参数的故障状态的多个现场可编程门阵列7820(安全FPGA)数据通信。Referring to Figure 78, the dialysis system includes at least one processor and memory for storing program instructions that, when executed, communicate with a software application layer 7805. The software application layer 7805 interfaces with the main controller 7810, which is in data communication with multiple Field Programmable Gate Arrays 7815 (controlling FPGAs) responsible for controlling the various pumps, sensors and valves and with monitoring the various pumps, sensors and Multiple Field Programmable Gate Array 7820 (Safe FPGA) data communication with valve operation for fault conditions beyond accepted operating parameters.
控制FPGA7815执行用于控制包括泵、传感器和阀的所有系统部件的操作的硬件指令，并且将部件的状态信息传输至控制器7810和安全FPGA7820，控制器7810进而处理信息并且将某些用于进一步处理和/或显示的数据传递至应用层7805，安全FPGA7820监视用于警报条件的状态信息，例如操作参数超出或不满足一个或多个预定的阈值。The control FPGA 7815 executes hardware instructions for controlling the operation of all system components including pumps, sensors, and valves, and transmits status information of the components to the controller 7810 and safety FPGA 7820, which in turn processes the information and uses some for further The processed and/or displayed data is passed to the application layer 7805, and the secure FPGA 7820 monitors status information for alarm conditions, such as operating parameters exceeding or failing to meet one or more predetermined thresholds.
如果控制FPGA7815产生指示警报条件或大体上指示终结或中止操作需要的数据，那么控制器7810或应用层7805可以发出一个或多个命令来终结操作。然而，独立地，安全FPGA7820接收数据并且可以直接地发出命令，或者以其他方式使一个或多个阀、泵或传感器的操作终结、中止或以其他方式改变状态。安全FPGA7820可以在从控制FPGA7815直接接收数据之后进行此操作，或者如果由控制器7810直接指令或由应用层7805直接指令的话独立地进行此操作。通过使安全FPGA直接地从控制FPGA7815接收数据以及从应用层7805和控制器7810接收指令，而没有在其之间的中介层，则系统可以响应于警报条件或用户指令更快速且可靠地导致关闭、中止或状态的其他修改。If controlling FPGA 7815 generates data indicative of an alarm condition or generally indicating a need to terminate or abort the operation, then controller 7810 or application layer 7805 may issue one or more commands to terminate the operation. Independently, however, safety FPGA 7820 receives data and may issue commands directly, or otherwise terminate, suspend, or otherwise change state the operation of one or more valves, pumps, or sensors. The secure FPGA 7820 may do this after receiving data directly from the controlling FPGA 7815 , or independently if instructed directly by the controller 7810 or by the application layer 7805 . By having the safety FPGA receive data directly from the control FPGA 7815 and instructions from the application layer 7805 and controller 7810 without intervening layers in between, the system can more quickly and reliably cause shutdown in response to an alarm condition or user instruction , abort, or other modification of status.
图形用户界面GUI
透析系统的实施方案还包括用户通过其与系统交互的界面。如上文讨论，控制器单元包括用于将图形用户界面呈现于用户的显示器。界面使得用户能够精确地测量和验证处方添加剂，并且提供功能来检查在系统中采用的一次性用品的以及处方添加剂的完整性和可靠性。Embodiments of the dialysis system also include an interface through which a user interacts with the system. As discussed above, the controller unit includes a display for presenting a graphical user interface to the user. The interface enables users to accurately measure and verify prescription additives, and provides functionality to check the integrity and authenticity of disposables and prescription additives employed in the system.
如上文讨论，透析系统包括秤，秤可以集成在控制器单元顶部的托架上，在便携式透析系统的储液器单元内，至底部单元的紧邻于用于吸附剂盒或输注液的保持器的一侧，或者在任何其他位置。由数字秤所采取的测量读数通过在集成到顶部控制器单元中的显示器上显示的图形用户界面(GUI)显示。As discussed above, the dialysis system includes scales, which may be integrated on the bracket on top of the controller unit, within the reservoir unit of the portable dialysis system, to the bottom unit next to the holder for the sorbent cartridge or infusion fluid. side of the device, or in any other location. Measurement readings taken by the digital scale are displayed through a Graphical User Interface (GUI) displayed on a display integrated into the top controller unit.
在一个实施方案中，控制器单元根据用户的处方进行编程。这可以通过初始设置来完成，在初始设置中用户将处方添加剂的所有包一个接一个地放置在秤托盘上。由数字秤进行的测量结果被记录且存储在内部存储器中。控制器因此能够获取关于添加剂名称和处方重量的数据。因此，当在开始透析过程之前任何处方添加剂的包被放置在用于测量的秤上时，控制器将测量到的重量与存储在内部存储器中的处方的重量进行比较。在测量到的重量和正确的或处方的重量之间有任何差异的情况下，控制器指导GUI显示警报或指导音频产生单元产生听觉警报。因此，这样的警报可以是视觉的，例如在GUI屏幕上的闪烁错误消息，并且还可以伴随有听觉警报。可替代地，用户不被允许继续透析设置过程。In one embodiment, the controller unit is programmed according to the user's prescription. This can be done with an initial setup where the user places all the packages of the prescription additive one after the other on the scale tray. Measurements made by the digital scale are recorded and stored in internal memory. The controller is thus able to obtain data on the name of the additive and the weight of the prescription. Thus, when any package of prescription additives is placed on the scale for measurement before starting the dialysis process, the controller compares the measured weight with the weight of the prescription stored in the internal memory. In the event of any discrepancy between the measured weight and the correct or prescribed weight, the controller directs the GUI to display an alarm or directs the audio generating unit to generate an audible alarm. Thus, such an alert may be visual, such as a flashing error message on a GUI screen, and may also be accompanied by an audible alert. Alternatively, the user is not allowed to continue the dialysis setup process.
图79示出了数据的示例性表格，用于可以作为文件、平面文件或表格存储在便携式透析系统的内部存储器中的处方添加剂。列790l描述了包内容物并且列7902示出了相应的重量。如可以从列7902看到，不同的包装之间的重量差是几克，这可以由数字秤读取。在一个实施方案中，本发明的数字秤被设计为具有0.1gm量级的重量分辨率，考虑到添加剂的重量，这提供大于5倍分辨率优点，更优选的是10倍分辨率优点。该分辨率足以区分通常使用的添加剂。Figure 79 shows an exemplary table of data for a prescription additive that may be stored as a file, flat file, or table in the internal memory of the portable dialysis system. Column 7901 describes the package contents and column 7902 shows the corresponding weight. As can be seen from column 7902, the weight difference between the different packages is a few grams, which can be read by the digital scale. In one embodiment, the digital scale of the present invention is designed to have a gravimetric resolution on the order of 0.1 gm, which provides greater than a 5-fold resolution advantage, more preferably a 10-fold resolution advantage, taking into account the weight of the additive. This resolution is sufficient to distinguish commonly used additives.
可选地，数字秤的结构被设计成使得称重过程不受用户将处方添加剂的包放置在秤上的方式影响。这是因为本发明中的秤的结构包括在多个悬挂点处的多个重量敏感构件。例如，在一个实施方案中，秤包括在三点悬挂上的三个传感器。总重量由秤系统计算，作为由所有传感器测量到的重量的和。使用这种计算方案的优点是包重量不需要均匀地分布在秤平台上。因此，即使包被放置在秤托盘上略微地偏向一侧，平坦或碾碎，将不影响由秤进行的重量测量的精确度。也就是说，用户不受其将包放置在秤上的方式束缚。Optionally, the structure of the digital scale is designed so that the weighing process is not affected by the way the user places the packet of the prescription additive on the scale. This is because the structure of the scale in the present invention includes multiple weight sensitive members at multiple suspension points. For example, in one embodiment, the scale includes three sensors on a three-point suspension. The total weight is calculated by the scale system as the sum of the weights measured by all sensors. The advantage of using this calculation scheme is that the bale weight does not need to be evenly distributed across the scale platform. Thus, even if a bag is placed on the scale tray slightly to one side, flat or crushed, it will not affect the accuracy of the weight measurement made by the scale. That is, the user is not bound by how he or she places the bag on the scale.
应当进一步理解的是，传感器重量可以通过使用任何本领域中已知的计算方法而被确定。在一个实施方案中，与秤数据通信的处理器从秤接收数据读数并且按照如下确定重量：It should be further understood that sensor weight may be determined using any calculation method known in the art. In one embodiment, a processor in data communication with the scale receives a data reading from the scale and determines the weight as follows:
传感器_重量(i)＝Kl(i)*ADC(读数)+K0(i)sensor_weight(i)=Kl(i)*ADC(reading)+K0(i)
袋_重量＝(传感器_重量(0)+传感器_重量(1)+传感器_重量(2)+传感器_重量(3))/4bag_weight = (sensor_weight(0) + sensor_weight(1) + sensor_weight(2) + sensor_weight(3))/4
如上文关于图16所讨论，便携式透析系统具有暴露的读取器1605，例如条形码读取器或RFID标签读取器，其可用于读取处方添加剂的包上的编码或标签。对于初始设置，用户将优选地通过读取器1605扫过处方添加剂的包上的所有编码/标签。可以通过提示用户将处方添加剂的每个包扫过读取器1605的初始GUI消息来帮助用户。在进行这种操作时，读取器获得关于添加剂的识别信息并且将该识别信息传输至存储在存储器中的内部表。在该初始设置之后，在开始透析之前无论何时处方添加剂要被加入透析液中，所涉及的包的识别信息(由读取器1605读取)被与在初始设置期间已经存储在内部表中的用于该添加剂的识别信息进行比较。这帮助验证正确的添加剂已经被选择用于与透析液共同使用，并且帮助排除任何伪造的添加剂。可以通过手动输入关于添加剂的身份和重量的数据或通过至详细描述添加剂的身份和量的处方的远距离访问来产生内部表的内容。As discussed above with respect to FIG. 16, the portable dialysis system has an exposed reader 1605, such as a barcode reader or RFID tag reader, which can be used to read the code or label on the pack of prescription additives. For initial setup, the user will preferably scan through the reader 1605 all codes/labels on the pack of prescription additives. The user may be assisted by an initial GUI message prompting the user to swipe each packet of prescription additive across the reader 1605. In doing so, the reader obtains identification information about the additive and transmits this identification information to an internal table stored in memory. After this initial setup, whenever a prescription additive is to be added to the dialysate before starting dialysis, the identification information (read by the reader 1605) of the package involved is compared with that already stored in the internal table during the initial setup The identifying information for the additive is compared. This helps verify that the correct additive has been selected for use with the dialysate and helps rule out any falsified additives. The contents of the internal table may be generated by manual entry of data regarding the identity and weight of the additive or by remote access to a prescription detailing the identity and amount of the additive.
在一个实施方案中，本发明的GUI由驻留在控制器单元中的处理器存储和执行的多个程序指令产生。一组程序指令被设计成使用户经过用于验证待被使用的添加剂的身份和量的过程。第一GUI屏幕提示用户将添加剂袋上的条形码暴露于条形码读取器。本领域技术人员要理解的是，该识别机构可以是条形码、RFID标签或其他电子标签，并且读取器可以是条形码读取器、RFID标签读取器或其他电子标签读取器。读取器读取被编码的信息，使用处理器来处理该信息，并且将处理过的信息传输至存储器。存储器具有将处理过的信息翻译成添加剂的身份的程序例程。在一个实施方案中，通过将各种识别符与具体的添加剂名称匹配的表格来促进上述翻译。该表格可以在程序之前被手动地输入，或者从服务器通过有线或无线连接至控制器进行下载。In one embodiment, the GUI of the present invention is generated by a plurality of program instructions stored and executed by a processor resident in the controller unit. A set of program instructions is designed to take the user through a process for verifying the identity and amount of the additive to be used. The first GUI screen prompts the user to expose the barcode on the additive bag to the barcode reader. Those skilled in the art will understand that the identification mechanism may be a barcode, RFID tag or other electronic tags, and the reader may be a barcode reader, RFID tag reader or other electronic tag readers. A reader reads the encoded information, processes the information using a processor, and transmits the processed information to memory. The memory has program routines that translate the processed information into the identity of the additive. In one embodiment, the above translation is facilitated by a table matching various identifiers to specific additive names. The form can be entered manually prior to the procedure, or downloaded from a server via a wired or wireless connection to the controller.
一旦获得了添加剂身份，GUI就将添加剂的身份通信至用户并且指令用户将添加剂放置在秤上。数字秤称重添加剂，并且将测量到的重量通信至第二表格。第二表格将添加剂身份与预期的重量进行映射。该第二表格可以在程序之前被手动地输入，或者从服务器通过有线或无线连接至控制器进行下载。如果添加剂身份和测量到的重量匹配，则用户被指令打开包并且将内容物倾倒到合适的位置中。这个过程对于所有的添加剂进行重复。在一个实施方案中，如果在包的身份及其重量之间存在差异或者如果包的被编码的身份不能被读取或是未知的话，则不允许用户继续该过程。因此，该系统提供一步骤或二步骤验证机制：a)单独地使用数字秤，或b)与条形码或标签读取器组合来使用数字秤，这确保用户在他或她的占有中具有全部所需的添加剂并且正确的添加剂正被使用且不是伪造的或不合适的。Once the additive identity is obtained, the GUI communicates the identity of the additive to the user and instructs the user to place the additive on the scale. The digital scale weighs the additive and communicates the measured weight to a second table. The second table maps additive identities to expected weights. This second form can be entered manually prior to the procedure, or downloaded from a server via a wired or wireless connection to the controller. If the additive identity and the measured weight match, the user is instructed to open the bag and dump the contents into place. This process is repeated for all additives. In one embodiment, the user is not allowed to proceed with the process if there is a discrepancy between the identity of the bag and its weight or if the encoded identity of the bag cannot be read or is unknown. Thus, the system provides a one-step or two-step authentication mechanism: a) using the digital scale alone, or b) using the digital scale in combination with a barcode or label reader, which ensures that the user has all required additives and the correct additives are being used and not counterfeit or inappropriate.
参照图80，示出了表示用于初始化透析治疗的另一个过程8000的流程图。在一个实施方案中，控制器单元800l包括至少一个处理器和存储多个程序指令的存储器。当由处理器执行时，程序指令产生显示在控制器显示器上的多个图形用户界面，其指导用户通过一系列设计成可靠获取并测量用于透析治疗所需的添加剂的动作。第一图形用户界面被产生，用户可以通过其来提示系统初始化添加剂核算过程800l。初始提示可以通过用于初始化过程的特定图标或者可以作为部分的较大系统设置发生。Referring to FIG. 80 , there is shown a flowchart representative of another process 8000 for initiating a dialysis treatment. In one embodiment, the controller unit 8001 includes at least one processor and memory storing a plurality of program instructions. When executed by the processor, the program instructions generate a plurality of graphical user interfaces displayed on the controller display that guide the user through a series of actions designed to reliably obtain and measure additives needed for dialysis treatment. A first graphical user interface is generated through which the user may prompt the system to initiate the additive accounting process 8001. The initial prompt can occur through a specific icon for the initialization process or can be part of a larger system setup.
然后产生8003第二图形用户界面，其以文本或图形形式显示所需的添加剂，优选地包括实际添加剂包装的视觉图像以允许用户可视地比较所需的添加剂与用户已经得到的产品。然后用户被提示8005以指示他是否希望使用条形码扫描或通过重量验证添加剂。如果用户通过例如按下图标指示他希望使用条形码扫描，则产生8007第三图形用户界面，提示用户将第一添加剂穿过条形码扫描器。然后用户将添加剂穿过条形码扫描器，优选地以任何顺序，记录读取结果。应当理解的是，条形码扫描器可以包括灯，例如红灯，其在成功读取时改变颜色，例如改变成绿色。A second graphical user interface is then generated 8003 which displays the desired additive in textual or graphical form, preferably including a visual image of the actual additive packaging to allow the user to visually compare the desired additive with the product the user has already obtained. The user is then prompted 8005 to indicate whether he wishes to use barcode scanning or verify the additive by weight. If the user indicates that he wishes to scan using a barcode, eg by pressing an icon, a third graphical user interface is generated 8007 prompting the user to pass the first additive through the barcode scanner. The user then passes the additives through the barcode scanner, preferably in any order, and records the reads. It should be appreciated that the barcode scanner may include a light, eg a red light, which changes color, eg to green, upon a successful read.
如果系统成功地读取条形码，则其通过相对于存储在存储器中的表格检查代码来处理8009该代码。存储在存储器中的表格将条形码与特定的添加剂相关联。一旦特定的添加剂被识别，则采用复选标记或高亮来更新8011如上文描述的第二图形用户界面，以指示哪个添加剂已被成功扫描并且用户被指令将该添加剂放在一边。这个过程对于所有的添加剂来说进行重复8019。在一个实施方案中，一旦所有的添加剂被高亮或复选，则系统就自动地前进至透析设置或初始化过程中的下一个步骤。在另一个实施方案中，一旦所有的添加剂被高亮或复选，则系统就呈现图形用户界面，该图形用户界面告知用户所有的添加剂已经被记录，之后用户手动地使系统前进至透析设置或初始化过程中的下一个步骤。应当理解的是，虽然使用的是术语条形码，但是还可以使用任何电子标签或标记系统。If the system successfully reads the barcode, it processes 8009 the code by checking the code against a table stored in memory. A table stored in memory associates barcodes with specific additives. Once a particular additive is identified, the second graphical user interface as described above is updated 8011 with a checkmark or highlight to indicate which additive has been successfully scanned and the user is instructed to put that additive aside. This process is repeated 8019 for all additives. In one embodiment, once all additives are highlighted or checked, the system automatically proceeds to the next step in the dialysis setup or initialization process. In another embodiment, once all additives are highlighted or checked, the system presents a graphical user interface that informs the user that all additives have been recorded, after which the user manually advances the system to the dialysis setup or The next step in the initialization process. It should be understood that although the term barcode is used, any electronic labeling or marking system may be used.
如果对于任何扫描步骤8009来说条形码不被识别、添加剂不具有条形码、或用户偏好使用如与扫描相反的称重来验证添加剂，则图形用户界面被呈现至用户，及其提示8013用户将第一添加剂放置在秤上。秤测量添加剂包装重量8015并且将测量到的重量同与特定添加剂相关的重量值的表格进行比较来识别添加剂。一旦被识别，则就采用复选标记或高亮更新8017如上文描述的第二图形用户界面，以指示哪个添加剂已被成功扫描，并且用户被指令将添加剂放在一边。这个过程对于所有的添加剂进行重复8019。在一个实施方案中，一旦所有的添加剂被高亮或复选，则系统就自动地前进至透析设置或初始化过程中的下一个步骤。在另一个实施方案中，一旦所有的添加剂被高亮或复选，则系统就呈现图形用户界面，该图形用户界面告知用户所有的添加剂已经被记录，之后用户手动地使系统前进至透析设置或初始化过程中的下一个步骤。应当理解的是，虽然使用的是术语条形码，但是还可以使用任何电子标签或标记系统。If the barcode is not recognized for any of the scan steps 8009, the additive does not have a barcode, or the user prefers to verify the additive using weighing as opposed to scanning, a GUI is presented to the user and it prompts 8013 the user to place the first Additives are placed on the scale. The scale measures the additive package weight 8015 and compares the measured weight to a table of weight values associated with a particular additive to identify the additive. Once identified, the second graphical user interface as described above is updated 8017 with a check mark or highlight to indicate which additive has been successfully scanned and the user is instructed to put the additive aside. This process is repeated 8019 for all additives. In one embodiment, once all additives are highlighted or checked, the system automatically proceeds to the next step in the dialysis setup or initialization process. In another embodiment, once all additives are highlighted or checked, the system presents a graphical user interface that informs the user that all additives have been recorded, after which the user manually advances the system to the dialysis setup or The next step in the initialization process. It should be understood that although the term barcode is used, any electronic labeling or marking system may be used.
如果添加剂不被识别，则用户被告知添加剂不是治疗过程的一部分并且被提示称重适当的添加剂。在另一个实施方案中，如果用户不能扫描或称重已识别的添加剂，则用户不被允许继续初始化或设置过程。If the supplement is not recognized, the user is informed that the supplement is not part of the treatment process and is prompted to weigh the appropriate supplement. In another embodiment, if the user is unable to scan or weigh the identified additive, the user is not allowed to proceed with the initialization or setup process.
本领域技术人员要理解的是，虽然上文提到的验证程序已经对处方添加剂进行了描述，但相同的程序还可以被扩展至与透析系统共同使用的一次性部件，例如吸附剂盒和其他一次性用品。It will be appreciated by those skilled in the art that while the validation procedures mentioned above have been described for prescription additives, the same procedures can also be extended to disposable components used with dialysis systems, such as sorbent cartridges and other Disposable items.
应当进一步理解的是，扫描和称重添加剂的过程可以被一体化和自动化。如上文讨论，可以提示用户初始化添加剂称重过程，并且可以显示对于治疗所需的项目的显示。用户将添加剂放置在秤上，该秤具有紧邻于或一体化在其中的条形码读取器。在一个实施方案中，用户被提示将添加剂放置在特定的位置或配置中来确保条形码可以被适当地读取。当将添加剂放置在具有一体化的或组合的条形码读取器的秤上时，条形码读取器扫描添加剂，尝试识别条形码，并且如果被识别，则通过在显示器上复选或高亮被识别的添加剂来处理项目。如果条形码读取器不能够识别添加剂，如果系统需要另外的补充检查，或者如果系统希望获得或以其他方式记录重量信息，则秤测量重量并且尝试相对于存储的值来识别添加剂。如果被识别，则系统通过在显示器上复选或高亮被识别的添加剂来处理项目。秤测量和条形码读取器可以因此发生，而不必将添加剂从一个地点或位置运动至另一个地点或位置。It should be further understood that the process of scanning and weighing additives can be integrated and automated. As discussed above, the user may be prompted to initiate the additive weighing process, and a display of items needed for the treatment may be displayed. The user places the additive on a scale that has a barcode reader adjacent to or integrated therein. In one embodiment, the user is prompted to place the additive in a specific location or configuration to ensure the barcode can be read properly. When an additive is placed on a scale with an integrated or combined barcode reader, the barcode reader scans the additive, attempts to recognize the barcode, and if recognized, by checking or highlighting the recognized Additives to handle items. If the barcode reader is unable to identify the additive, if the system requires another supplementary check, or if the system wishes to obtain or otherwise record weight information, the scale measures the weight and attempts to identify the additive against the stored value. If identified, the system processes the item by checking or highlighting the identified additive on the display. Scale measurements and barcode readers can thus take place without having to move the additive from one site or location to another.
应当进一步理解的是，可以将添加剂插入到将自动地把每个添加剂放下、放置或以其他方式定位入秤/条形码读取器上的适当位置中的保持容器、滑槽、圆筒、盒子、桶或暂存区域中。因此，用户可以将所有的添加剂放置到单一的容器中，激活系统，并且使每个添加剂依次地定位在秤上并且被自动识别。可以提示用户在每个添加剂被识别之后移除每个添加剂或者可以提示用户允许所有的添加剂被首先处理。It should be further understood that additives may be inserted into holding containers, chutes, cylinders, boxes, bucket or staging area. Thus, the user can place all of the additives into a single container, activate the system, and have each additive in turn positioned on the scale and automatically identified. The user may be prompted to remove each additive after it is identified or may be prompted to allow all additives to be processed first.
应当进一步理解的是，添加剂可以在识别之后自动地、在识别之后手动地、以及在血液滤器和/或吸附剂盒被安装之前或之后被加入到系统中。在一个实施方案中，便携式透析系统的顶部单元或底部单元也优选地具有电子接口，例如以太网连接部或USB端口，以使得能够直接连接到网络，从而促进远程处方验证、依从性警戒及其他远程服务操作。USB端口还允许直接连接到配件产品，例如血压监护器或血细胞比容/饱和化监视器。接口被电子地隔离，从而确保患者安全性，而与接口连接装置的品质无关。It should be further understood that additives may be added to the system automatically after identification, manually after identification, and before or after the hemofilter and/or sorbent cartridge is installed. In one embodiment, the top or bottom unit of the portable dialysis system also preferably has an electronic interface, such as an Ethernet connection or a USB port, to enable direct connection to a network, facilitating remote prescription verification, compliance vigilance, and others Remote service operation. The USB port also allows direct connection to accessory products such as blood pressure monitors or hematocrit/saturation monitors. The interface is electronically isolated, ensuring patient safety regardless of the quality of the interface connection.
在另一个实施方案中，透析机包括可被操纵成使被加载有歧管的透析机以治疗模式或预充模式开始操作的界面，其以具有触摸屏按钮、物理键盘或鼠标的图形用户界面的形式。当被指示以治疗模式操作时，控制器产生信号(响应于该治疗模式命令)以使歧管阀从打开、预充状态切换至关闭治疗状态。当被指示以预充模式操作时，控制器产生信号(响应于该预充模式命令)以使歧管阀从关闭治疗状态切换至打开预充状态。本领域技术人员要理解的是，所有上文提到的控制和用户命令功能通过结合一个或多个执行实施上文提到的指令(存储在本地存储器中)的编程的处理器来实现。In another embodiment, the dialysis machine includes an interface that can be manipulated to initiate operation of the dialysis machine loaded with the manifold in either a therapy mode or a priming mode, in the form of a graphical user interface with touch screen buttons, a physical keyboard, or a mouse. form. When instructed to operate in a therapy mode, the controller generates a signal (in response to the therapy mode command) to switch the manifold valve from an open, priming state to a closed therapy state. When instructed to operate in the priming mode, the controller generates a signal (in response to the priming mode command) to switch the manifold valve from the closed therapy state to the open priming state. Those skilled in the art will appreciate that all of the above mentioned control and user command functions are implemented in conjunction with one or more processors executing a program implementing the above mentioned instructions (stored in local memory).
当被合适地致动时，系统可以至少以预充模式和治疗模式操作，其可以包括其他的操作模式(例如血液透析、血液滤过或简单的是非预充模式)。关于示例性的治疗模式并且参照图84，以透析模式操作的透析系统8400包括透析器8402、吸附剂再生系统(例如盒)8412、歧管8410、通过端口进入歧管8410中的输注液源8416、以及新鲜透析液从其经由端口而被输入返回到歧管8410中的储液器8415。在操作中，血液进入血液管线840l，通过端口进入歧管8410中，通过在第一位置中的二通阀842l并且进入透析器8402中。已净化的血液通过出口8403离开透析器8402，通过在第一位置中的二通阀8422，并且通过端口进入歧管8410中。血液穿过歧管，穿过多个阀8417，如上文关于歧管8410描述，并且从端口出来并进入到进入患者的血液管线8423中。When suitably activated, the system can operate in at least a priming mode and a therapy mode, which can include other modes of operation (such as hemodialysis, hemofiltration or simply a non-priming mode). Regarding an exemplary therapy mode and referring to FIG. 84, a dialysis system 8400 operating in a dialysis mode includes a dialyzer 8402, a sorbent regeneration system (e.g., a cartridge) 8412, a manifold 8410, a source of infusion fluid through a port into the manifold 8410 8416, and reservoir 8415 from which fresh dialysate is input via port back into manifold 8410. In operation, blood enters blood line 8401, passes through a port into manifold 8410, passes through 2-way valve 8421 in the first position and into dialyzer 8402. Purified blood exits the dialyzer 8402 through the outlet 8403, through the two-way valve 8422 in the first position, and through the port into the manifold 8410. Blood passes through the manifold, through a plurality of valves 8417 as described above with respect to manifold 8410, and out the ports and into blood line 8423 into the patient.
同时，从源8416传递的输注液通过端口进入到歧管8410中，通过歧管8410，通过另一个端口出来，并且进入储液器8415中，透析液经由透析液管线8424从储液器8415被递送并进入透析器8402中。在穿过透析器8402之后，透析液穿过外管线8425并且通过端口返回到歧管8410中，其在歧管8410经由端口被引导至基于吸附剂的透析液再生系统8412。已再生的透析液经由端口返回通过歧管8410，并且与新的透析液(如果并且需要时)一起再循环通过透析器8402。为了管理透析液流体流动，储液器8415用于储存已再生的透析液，如果并且需要时。在一个实施方案中，储液器保持5升的透析液，并且具有保持达10升的来自患者的透析液和流出物的容量。Simultaneously, infusion fluid delivered from source 8416 enters manifold 8410 through a port, passes through manifold 8410, exits through another port, and enters reservoir 8415 from which dialysate is transferred via dialysate line 8424 is delivered and enters the dialyzer 8402. After passing through the dialyzer 8402, the dialysate passes through the outer line 8425 and is ported back into the manifold 8410 where it is directed via a port to the sorbent-based dialysate regeneration system 8412. Regenerated dialysate is ported back through manifold 8410 and recirculated through dialyzer 8402 along with fresh dialysate (if and as needed). To manage dialysate fluid flow, reservoir 8415 is used to store regenerated dialysate, if and when needed. In one embodiment, the reservoir holds 5 liters of dialysate and has a capacity to hold up to 10 liters of dialysate and effluent from the patient.
关于示例性的预充模式并且参照图85，以预充模式操作的透析系统8500包括透析器8502、吸附剂再生系统(例如盒)8512、歧管8510、输注液源8516和储液器8515。在操作中，从患者(例如图84中的8401)到歧管8510中的血液管线不被连接，且因此没有血液正在流入或能够流入歧管8510。相反，从源8515输送的透析液通过多个端口进入歧管8510中并且通过连接到二通阀端口8522的透析液管线8524。Regarding an exemplary priming mode and referring to FIG. 85 , a dialysis system 8500 operating in a priming mode includes a dialyzer 8502, a sorbent regeneration system (e.g., a cartridge) 8512, a manifold 8510, an infusion fluid source 8516, and a reservoir 8515. . In operation, the blood line from the patient (eg, 8401 in FIG. 84 ) into the manifold 8510 is not connected, and thus no blood is flowing or can flow into the manifold 8510. Instead, dialysate delivered from source 8515 enters manifold 8510 through multiple ports and through dialysate line 8524 connected to two-way valve port 8522 .
在一个优选的实施方案中，单一的二通阀8517结合到歧管8510的物理主体中，并且被操纵成在治疗操作模式和预充操作模式之间切换，如上文讨论。在本实施方案中，歧管8510包括二通阀8517，其如果被激活或者被从第一位置(例如关闭)切换至第二位置(例如打开)的话则导致歧管内的液体的内部流动路径的改变。由于这种流动路径改变，当阀被关闭时彼此流体地隔离的血液及透析液回路现在被置于与彼此流体连通。优选地，没有另外的阀或开关需要被操纵以实现这种状态改变，即促使分离的血液及透析液回路变得流体连接。In a preferred embodiment, a single two-way valve 8517 is incorporated into the physical body of the manifold 8510 and is manipulated to switch between a therapy mode of operation and a priming mode of operation, as discussed above. In this embodiment, the manifold 8510 includes a two-way valve 8517 that, if activated or switched from a first position (e.g., closed) to a second position (e.g., open), causes the internal flow path of the liquid within the manifold to be restricted. Change. Due to this change in flow path, the blood and dialysate circuits, which were fluidly isolated from each other when the valves were closed, are now placed in fluid communication with each other. Preferably, no additional valves or switches need to be manipulated to effect this change of state causing the separate blood and dialysate circuits to become fluidly connected.
阀切换可以通过任何本领域中已知的手段实现，包括通过物理地操纵在歧管表面上的机械控制部，或者电子地通过在具有用于根据用户选择的操作模式控制阀状态的控制器的透析机与集成到歧管表面中的阀接口之间的接口来操作透析机，促使改变阀状态。Valve switching may be accomplished by any means known in the art, including by physically manipulating a mechanical control on the manifold surface, or electronically by a controller with a controller for controlling the state of the valve according to a user-selected mode of operation. The interface between the dialysis machine and the valve interface integrated into the manifold surface to operate the dialysis machine causes a change of valve state.
在预充模式中，阀8517将被打开，从而使透析液流体流过泵以穿过歧管8510，经由管子8524、8503和二通阀端口8522进入透析器8502中，从透析器出来，经由二通阀端口852l和管子8525返回到歧管8510中，并且从歧管8510出来。因此，在预充模式中，阀8517确保透析液循环通过血液回路，从而将血液和透析液回路置于流体连通。在功能上，通过操纵二通阀8517的状态，将歧管8510置于预充模式中。In priming mode, valve 8517 will be opened allowing dialysate fluid to flow through the pump to pass through manifold 8510, into dialyzer 8502 via tubing 8524, 8503 and 2-way valve port 8522, out of the dialyzer via Two-way valve port 8521 and tubing 8525 return into and out of manifold 8510. Thus, in priming mode, valve 8517 ensures that dialysate is circulated through the blood circuit, thereby placing the blood and dialysate circuits in fluid communication. Functionally, by manipulating the state of the two-way valve 8517, the manifold 8510 is placed in the priming mode.
在透析液的特定体积被泵送到血液回路中并且通过其之后，二通阀被关闭。透析液的泵送可以或可以不继续。如果被继续，则新鲜的透析液仅循环通过透析液回路。残留的透析液保持在血液回路中。为了从血液回路清除透析液，患者连接到“来自患者管线”840l，如在图84中示出并且通常被称为动脉进入管线。“至患者管线”8423通常被称为静脉返回管线，或保持在废物容器上或连接到患者。After a certain volume of dialysate has been pumped into and through the blood circuit, the two-way valve is closed. The pumping of dialysate may or may not continue. If continued, fresh dialysate is only circulated through the dialysate circuit. Residual dialysate remains in the blood circuit. To purge dialysate from the blood circuit, the patient is connected to the "from patient line" 8401, as shown in Figure 84 and commonly referred to as the arterial access line. The "to-patient line" 8423 is commonly referred to as the venous return line, either held on a waste container or connected to the patient.
通过将系统置于治疗模式中，来自患者的血液被吸入血液回路中，传递进入歧管，通过泵，从歧管出来，通过透析器，返回到歧管中，并且返回从歧管出来。血液从而使残留的预充流体被‘驱逐’通过血液回路，在该过程中移除任何其余的气穴，并且进入废物容器或患者，取决于静脉返回管线的连接状态。在血液已经完全填充血液回路之后，系统停止血液泵或用户手动地停止泵。如果尚未被连接，则静脉返回管线然后连接到患者并且治疗继续。By placing the system in therapy mode, blood from the patient is drawn into the blood circuit, passed into the manifold, through the pump, out of the manifold, through the dialyzer, back into the manifold, and back out of the manifold. The blood thus 'expels' the remaining priming fluid through the blood circuit, removing any remaining air pockets in the process, and into a waste container or the patient, depending on the connection status of the venous return line. After blood has completely filled the blood circuit, the system stops the blood pump or the user stops the pump manually. If not already connected, the venous return line is then connected to the patient and therapy continues.
在另一个实施方案中，过滤器例如0.22μ过滤器可以用于帮助移除任何剩余的非期望物质，如果吸附剂罐不足以生产基本上无菌的透析液的话。在一个实施方案中，过滤器定位成与储液器输入管线共线，紧邻于歧管的端口E，并且在预充和操作期间都被使用。In another embodiment, a filter such as a 0.22μ filter can be used to help remove any remaining undesired material if the sorbent canister is insufficient to produce substantially sterile dialysate. In one embodiment, a filter is positioned in-line with the reservoir input line, next to port E of the manifold, and is used during both priming and operation.
通过使用这种预充系统，避免了必须使用另外的并且分离的一次性用品套件来仅预充回路的血液侧。特别地，这种途径不需要分离的盐水源，例如l升袋子的盐水，因此也不需要至分离的盐水源的连接器和管路，包括用于将血液管线连接到盐水的二管腔尖刺或单管腔尖刺。By using this priming system, it is avoided having to use an additional and separate disposable set to prime only the blood side of the circuit. In particular, this approach does not require a separate saline source, such as a 1 liter bag of saline, and therefore does not require connectors and tubing to a separate saline source, including a two-lumen tip for connecting blood lines to saline spines or single-lumen spines.
一次性试剂盒Disposable Kit
本文公开的透析系统的实施方案被设计为使用多个一次性部件。参照图8l，在一个实施方案中，用于系统的一次性用品8106以预组装在托盘8105上的包装运输。托盘8105放置在控制器单元810l工作空间的顶部，从而允许很容易到访问和管理所需的一次性用品，这对于家庭用户来说特别重要。控制器单元810l是防水的，使得在液体溢出的情况下，其应当不渗漏到顶部控制器单元810l中及损坏它。Embodiments of the dialysis systems disclosed herein are designed to use multiple disposable components. Referring to FIG. 81 , in one embodiment, the disposables 8106 for the system are shipped in pre-assembled packages on a pallet 8105 . The tray 8105 is placed on top of the controller unit 8101 workspace, allowing easy access and management of needed disposables, which is especially important for home users. The controller unit 8101 is waterproof so that in the event of a liquid spill it should not leak into the top controller unit 8101 and damage it.
在一个实施方案中，试剂盒8200容纳全部被预附接的歧管8202、透析器820l和管路8203。参照图82，一次性试剂盒8200包括透析器820l、歧管8202、管路8203、阀8204(作为歧管的一部分)、储液器袋8205，它们全部被预附接并且配置成用于由用户直接安装到透析机中。In one embodiment, the kit 8200 contains the manifold 8202, dialyzer 8201 and tubing 8203 all pre-attached. Referring to Figure 82, a disposable kit 8200 includes a dialyzer 8201, manifold 8202, tubing 8203, valve 8204 (as part of the manifold), reservoir bag 8205, all pre-attached and configured for use by The user installs directly into the dialysis machine.
更特别地，一次性部件，特别是完全一次性的血液及透析液回路被预包装在试剂盒(其包括透析器、歧管、管路、储液器袋、氨传感器和其他部件)中，并且然后由用户通过打开顶部单元的前部门(如上文讨论)安装，安装透析器并且以确保相对于非一次性部件例如压力传感器和其他部件对准的方式安装歧管。集成到前部门的内表面中的多个泵靴使得很容易地加载一次性部件。歧管仅需要被插入，并且没有泵管路需要被螺纹连接在滚动器和靴之间。这种打包的简单方法使得能够很容易地加载一次性用品和清洁系统。其还确保流动回路被适当地配置并且易于使用。在操作中，顶部单元附接到具有储液器的底部单元。More particularly, disposable components, especially fully disposable blood and dialysate circuits, are pre-packaged in kits (which include dialyzers, manifolds, tubing, reservoir bags, ammonia sensors, and other components), And then installed by the user by opening the front door of the top unit (as discussed above), installing the dialyzer and installing the manifold in a manner that ensures alignment relative to non-disposable components such as pressure sensors and other components. Multiple pump shoes integrated into the inner surface of the front door make it easy to load disposable components. The manifold only needs to be plugged in, and no pump lines need to be threaded between the roller and the shoe. This simple method of packaging makes it easy to load disposables and clean the system. It also ensures that the flow circuit is properly configured and easy to use. In operation, the top unit is attached to the bottom unit with the reservoir.
可选地，一次性部件特别是歧管包括基于电子的封锁(“e-封锁”)系统。图83是示出了本发明e-封锁系统的一个实施方案的功能框图。在一个实施方案中，e-封锁系统8300包括读取器830l，其探测并且读取内嵌在一次性物品8302例如一次性歧管、用于透析液再生中的一次性吸附剂和/或透析器中的识别数据8306。识别数据8306可以通过条型码、RFID标签、EEPROM、微芯片或任何其他的唯一识别要被用于透析系统8303的一次性物品8302的识别手段而被存储在一次性物品8302上。读取器8301相应地是条型码读取器、RFID读取器、微芯片读取器或任何其他的相应于所采用的识别技术的读取器，如本领域技术人员已知。在一个实施方案中，读取器830l连接到收发器，用于通过网络8304无线地连接到远程数据库8305，例如国际互联网或本领域技术人员已知的任何其他公共或私人网络。在另一个实施方案中，读取器830l与识别数据8306直接对准。Optionally, the disposable components, particularly the manifold, include an electronically based lockout ("e-lockout") system. Fig. 83 is a functional block diagram showing an embodiment of the e-lockout system of the present invention. In one embodiment, the e-lockout system 8300 includes a reader 8301 that detects and reads disposable sorbents and/or dialysates embedded in disposable items 8302 such as disposable manifolds, used in dialysate regeneration and/or dialysate Identification data 8306 in the device. Identification data 8306 may be stored on the disposable 8302 by barcode, RFID tag, EEPROM, microchip, or any other means of identification that uniquely identifies the disposable 8302 to be used in the dialysis system 8303 . The reader 8301 is accordingly a barcode reader, an RFID reader, a microchip reader or any other reader corresponding to the identification technology employed, as known to a person skilled in the art. In one embodiment, the reader 8301 is connected to a transceiver for wirelessly connecting to a remote database 8305 through a network 8304, such as the Internet or any other public or private network known to those skilled in the art. In another embodiment, the reader 8301 is directly aligned with the identification data 8306 .
位于距透析系统远程的数据库8305存储多个关于可用于系统8303的一次性物品8302的信息。信息包括独特的识别数据8306以及用于相应一次性物品的信息，例如可靠性、就项目是否可能处于工作条件而言的可使用性、或项目是否已经由于缺陷而被制造商召回、其失效期(如果有的话)，和/或任何其他的将有利地对于本领域技术人员明显的这种附加值信息。A database 8305 located remotely from the dialysis system stores a variety of information regarding disposables 8302 available to the system 8303. Information includes unique identification data 8306 and information for the corresponding disposable item, such as reliability, usability in terms of whether the item may be in working condition, or whether the item has been recalled by the manufacturer due to a defect, its expiration date (if any), and/or any other such value-added information that would advantageously be apparent to those skilled in the art.
在操作中，当一次性物品8302例如透析器、歧管或血液滤器盒被加载到系统8303中时，读取器830l通过内嵌在项目8302上的识别数据8306探测一次性物品8302。该识别数据8306由读取器830l读取，该读取器又与数据库8305有线或无线通信，以基于识别数据8306请求更多的关于存储在其中的项目8302的信息，或基于识别数据8306证实项目8302的有效性或完整性。In operation, when a disposable 8302 such as a dialyzer, manifold or hemofilter cassette is loaded into the system 8303, the reader 8301 detects the disposable 8302 via identification data 8306 embedded on the item 8302. This identification data 8306 is read by a reader 8301, which in turn communicates with a database 8305 by wire or wirelessly to request further information about the item 8302 stored therein based on the identification data 8306, or to verify Item 8302 validity or completeness.
例如，在一个实施方案中，由读取器830l识别的透析器盒8302可能已经由于某个缺陷而被制造商召回。这种召回信息存储在数据库8305上并且作为由读取器830l通过网络8304发送至数据库8305的请求信号的结果而被返回至读取器830l。作为从数据库8305接收的召回信息的结果，控制由系统8303支撑的血液净化系统的微处理器不允许用户继续治疗。在一个实施方案中，这是通过中止将流体推进通过血液净化系统8303的流体回路的泵的功能来实现的。此外，音频/视觉警报也可以被显示成这种效果。For example, in one embodiment, the dialyzer cassette 8302 identified by the reader 8301 may have been recalled by the manufacturer due to a certain defect. This recall information is stored on the database 8305 and is returned to the reader 8301 as a result of a request signal sent by the reader 8301 to the database 8305 over the network 8304. As a result of the recall information received from database 8305, the microprocessor controlling the blood purification system supported by system 8303 does not allow the user to continue treatment. In one embodiment, this is accomplished by disabling the function of the pump that pushes fluid through the fluid circuit of the blood purification system 8303. Additionally, audio/visual alerts can also be displayed to this effect.
在另一个示例中，由读取器830l识别的透析器盒8302可能不是可信的。作为其结果，微处理器将不允许系统8303的血液净化系统的功能。因此，本发明的e-封锁系统8300在附接到歧管8303的一次性物品8302处于受损状态的情况下防止使用系统8303。In another example, the dialyzer cassette 8302 identified by the reader 8301 may not be authentic. As a result of this, the microprocessor will not allow the function of the blood purification system of system 8303. Thus, the e-lockout system 8300 of the present invention prevents use of the system 8303 if the disposable 8302 attached to the manifold 8303 is in a compromised state.
虽然已经图示并描述了目前被认为是本发明优选实施方案的内容，但本领域技术人员要理解的是，在不偏离本发明真正范围的情况下，可以作出各种改变和修改，并且等效物可以代替其中的元件。此外，在不偏离其中心范围的情况下，还可以作出许多修改以使具体的条件或材料适应于本发明的教导内容。因此，所希望的是本发明不限于作为用于实施本发明所设想的最好模式公开的具体实施方案，而且本发明将包括所有落入所附权利要求范围内的实施方案。While there has been illustrated and described what are presently considered to be preferred embodiments of the invention, it will be understood by those skilled in the art that various changes and modifications may be made without departing from the true scope of the invention, and etc. Effects can replace components. In addition, many modifications may be made to adapt a particular situation or material to the teachings of the invention without departing from its central scope. Therefore, it is intended that the invention not be limited to the particular embodiment disclosed as the best mode contemplated for carrying out this invention, but that the invention will include all embodiments falling within the scope of the appended claims.
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| PCT/US2014/035051WO2014161008A1 (en) | 2013-03-28 | 2014-04-22 | Manifold diaphragms |
| Publication Number | Publication Date |
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| CN105263542Atrue CN105263542A (en) | 2016-01-20 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201480029452.0APendingCN105263542A (en) | 2014-04-22 | 2014-04-22 | Manifold diaphragms |
| Country | Link |
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| EP (1) | EP2999497A4 (en) |
| CN (1) | CN105263542A (en) |
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| US20060226090A1 (en)* | 2005-04-08 | 2006-10-12 | Mission Medical, Inc. | Method and apparatus for blood separations |
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| EP2999497A1 (en) | 2016-03-30 |
| EP2999497A4 (en) | 2016-10-26 |
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| US11318248B2 (en) | Methods for heating a reservoir unit in a dialysis system | |
| US10857281B2 (en) | Disposable kits adapted for use in a dialysis machine | |
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