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CN104394900A - Pressure-Based Leak Detection in Extracorporeal Blood Processing Devices - Google Patents

Pressure-Based Leak Detection in Extracorporeal Blood Processing Devices Download PDF

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CN104394900A
CN104394900A CN201380028623.3A CN201380028623A CN104394900A CN 104394900 A CN104394900 A CN 104394900A CN 201380028623 A CN201380028623 A CN 201380028623A CN 104394900 A CN104394900 A CN 104394900A
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约翰·奥马霍尼
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Gambro Renal Products Inc
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/34Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/34Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
    • A61M1/3403Regulation parameters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/34Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
    • A61M1/3413Diafiltration
    • A61M1/3417Diafiltration using distinct filters for dialysis and ultra-filtration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/15Detection of leaks
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/18General characteristics of the apparatus with alarm
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/33Controlling, regulating or measuring
    • A61M2205/3331Pressure; Flow
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/33Controlling, regulating or measuring
    • A61M2205/3331Pressure; Flow
    • A61M2205/3358Measuring barometric pressure, e.g. for compensation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/50General characteristics of the apparatus with microprocessors or computers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/50General characteristics of the apparatus with microprocessors or computers
    • A61M2205/502User interfaces, e.g. screens or keyboards
    • A61M2205/505Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches

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Abstract

本文所述的体外血液处理装置包括被配置为检测从体外血液处理装置中的一个或多个液体回路泄漏的液体的部件,以及检测体外血液处理装置中的液体泄漏的方法。用于检测泄漏的部件包括由一个或多个流体填充的压力管路连接到一个或多个压力传感器上的一个或多个本地压力端口的一个或多个远程压力端口。压力管路中的流体将由任何收集的液体施加在远程压力端口上的压力传递到压力传感器的本地压力端口。

The extracorporeal blood treatment apparatus described herein includes components configured to detect leakage of fluid from one or more fluid circuits within the extracorporeal blood treatment apparatus, as well as methods for detecting fluid leakage within the extracorporeal blood treatment apparatus. The components for detecting leakage include one or more fluid-filled pressure lines connected to one or more remote pressure ports of one or more pressure sensors and one or more local pressure ports. The fluid in the pressure lines transmits the pressure exerted by any collected fluid on the remote pressure ports to the local pressure ports of the pressure sensors.

Description

体外血液处理装置中基于压力的泄漏检测Pressure-Based Leak Detection in Extracorporeal Blood Processing Devices

交叉援引cross reference

本申请要求2012年12月31日提交的美国临时申请第61/747,718号的权益,其公开内容通过援引结合在此。This application claims the benefit of US Provisional Application No. 61/747,718, filed December 31, 2012, the disclosure of which is incorporated herein by reference.

技术领域technical field

本文描述结合有用于基于压力进行泄漏检测的部件的体外血液处理装置及其使用方法。Described herein are extracorporeal blood treatment devices incorporating means for pressure-based leak detection and methods of use thereof.

背景技术Background technique

体外血液处理包括从病人取得血液,在病人体外处理血液,并将处理后的血液返回给病人。体外血液处理通常被用于从病人的血液析取不需要的物质或分子,和/或将有益物质或分子添加到血液中。体外血液处理用于不能从他们的血液中有效地去除物质的病人,例如在患有临时或永久肾衰竭的病人的情况下。例如,这些和其它的病人可经受体外血液处理以向他们的血液添加物质或从他们的血液去除物质,从而保持酸碱平衡或去除多余体液。Extracorporeal blood processing involves obtaining blood from a patient, processing the blood outside the patient's body, and returning the processed blood to the patient. Extracorporeal blood treatment is commonly used to extract unwanted substances or molecules from a patient's blood and/or to add beneficial substances or molecules to the blood. Extracorporeal blood treatment is used for patients who cannot effectively remove substances from their blood, for example in the case of patients suffering from temporary or permanent renal failure. For example, these and other patients may undergo extracorporeal blood treatment to add substances to or remove substances from their blood, to maintain acid-base balance or to remove excess body fluids.

通常,通过以连续流的方式采样病人的血液,并通过将血液引入到至少部分地由半透膜限定的过滤器的血液腔中,来执行体外血液处理。根据处理的类型,半透膜可以选择性地允许包含在血液中的不需要的物质从血液腔穿过该膜到辅助腔,并且可以选择性地允许包含在进入辅助腔中的液体中的有益物质穿过该膜到进入血液腔中的血液中。Typically, extracorporeal blood treatment is performed by sampling a patient's blood in a continuous flow and by introducing the blood into the blood cavity of a filter defined at least in part by a semipermeable membrane. Depending on the type of treatment, a semipermeable membrane may selectively allow unwanted substances contained in the blood to pass through the membrane from the blood lumen to the auxiliary lumen, and may selectively allow beneficial substances contained in fluid entering the auxiliary lumen. Substances pass through the membrane into the blood entering the blood cavity.

一些体外血液处理可以用相同的机器来执行。在超滤(UF)处理中,不需要的物质通过对流穿过膜在辅助腔中从血液中去除。Some extracorporeal blood treatments can be performed with the same machines. In an ultrafiltration (UF) process, unwanted substances are removed from blood in an auxiliary chamber by convection across a membrane.

在血液过滤(HF)处理中,如在UF中一样,血液流过至少部分地由半透膜限定的腔,且在血液穿过过滤器之前或之后并在其返回到病人之前,通常通过将流体引入到血液中,将有益物质添加到血液中。In a hemofiltration (HF) process, as in UF, blood flows through a lumen at least partially defined by a semipermeable membrane, and either before or after the blood passes through the filter and before it is returned to the patient, the The fluid is introduced into the blood, adding beneficial substances to the blood.

在血液透析(HD)处理中,将含有有益物质的辅助流体引入到过滤器的辅助腔中。血液中的不需要的物质通过扩散穿过半透膜并渗入到辅助流体中,且辅助流体的有益物质可以穿过膜并渗入到血液中。In hemodialysis (HD) treatment, an auxiliary fluid containing beneficial substances is introduced into the auxiliary lumen of the filter. Unwanted substances in the blood pass through the semipermeable membrane by diffusion and penetrate into the auxiliary fluid, and beneficial substances of the auxiliary fluid can pass through the membrane and penetrate into the blood.

在血液透析滤过(HDF)处理中,如在HD中一样,血液和辅助流体交换它们的物质,并且进一步地,如在HF中一样,典型地通过在返回到病人之前将流体引入到处理后的血液中,来将物质添加到血液中;不需要的物质通过对流和扩散从血液中去除。In hemodiafiltration (HDF) treatment, as in HD, blood and auxiliary fluid exchange their substances, and further, as in HF, typically by introducing the fluid into the post-treatment to add substances to the blood; unwanted substances are removed from the blood by convection and diffusion.

在使用辅助流体的那些处理中,辅助流体通过过滤器的辅助腔并接收通过扩散和/或对流穿过膜的血液中的不需要的物质。然后,从该滤波器中引出该液体:其通常被称为废液,并且被发送到排液管,或者被发送到容器然后被排放到排水管。In those treatments using an auxiliary fluid, the auxiliary fluid passes through the auxiliary lumen of the filter and receives unwanted substances in the blood that pass through the membrane by diffusion and/or convection. The liquid is then drawn from the filter: it is commonly called waste and is sent to a drain, or to a container and then discharged to a drain.

用于实现这些治疗的体外血液处理装置通常包括许多部件,如:泵、阀、管、传感器等,它们被彼此连接以形成多个液体回路。在使用装置的过程中,一个或多个液体回路的不期望的液体泄漏可能发生在各种部件之间的一个或多个接合点,或者由于一个或多个部件损坏或故障而产生。The extracorporeal blood treatment devices used to achieve these treatments generally include many components, such as: pumps, valves, tubes, sensors, etc., which are connected to each other to form multiple fluid circuits. During use of the device, undesired fluid leakage from one or more fluid circuits may occur at one or more junctions between various components, or due to damage or failure of one or more components.

虽然在体外血液处理装置中的液体回路被设计为在所有操作条件下发挥作用而不发生泄漏,但在某些情况下,体外血液处理装置中的一个或多个液体回路可能潜在地发生泄漏。除了造成材料的不期望的损失之外,体外血液处理装置中液体回路的泄漏可能损坏装置,并可能危及病人的治疗。Although the fluid circuits in an extracorporeal blood treatment set are designed to function without leakage under all operating conditions, under certain circumstances one or more of the fluid circuits in an extracorporeal blood treatment set may potentially leak. In addition to causing undesired loss of material, leaks in fluid circuits in extracorporeal blood treatment devices can damage the device and potentially jeopardize patient treatment.

发明内容Contents of the invention

本文所述的体外血液处理装置包括被配置为检测从体外血液处理装置的一个或多个液体回路泄漏的液体的部件,以及检测体外血液处理装置的液体泄漏的方法。用于检测泄漏的部件包括由流体填充的压力管路连接到压力传感器上的本地压力端口的远程压力端口。压力管路中的流体将由任何收集的液体施加在远程压力端口上的压力传递到压力传感器的本地压力端口。The extracorporeal blood treatment devices described herein include components configured to detect fluid leakage from one or more fluid circuits of an extracorporeal blood treatment device, and methods of detecting fluid leakage from an extracorporeal blood treatment device. The means for detecting leaks includes a remote pressure port connected by a fluid-filled pressure line to a local pressure port on the pressure sensor. The fluid in the pressure line transfers the pressure exerted by any collected liquid on the remote pressure port to the local pressure port of the pressure sensor.

在一个或多个实施例中,通过流体填充的压力管路将远程压力端口与压力传感器分离允许压力传感器电连接到控制单元,而无需电连接延伸到收集泄漏液体处的远程压力端口。相反,施加在远程压力端口上的压力通过流体填充的压力管路传送到压力传感器的本地压力端口。In one or more embodiments, isolating the remote pressure port from the pressure sensor by a fluid-filled pressure line allows the pressure sensor to be electrically connected to the control unit without the need for an electrical connection to the remote pressure port extending to where leaked fluid is collected. Instead, the pressure applied on the remote pressure port is transmitted to the local pressure port of the pressure sensor through a fluid-filled pressure line.

在一个或多个实施例中,压力传感器可与控制单元一样位于壳体中,而该流体填充的压力管路延伸出壳体到该远程压力端口所处的液体收集器。压力传感器和控制单元之间的缩短的电连接会是有利的,因为从远程压力端口延伸到控制单元的较长电连接可潜在地导致电干扰(尤其是在收集泄漏液体的位置远离该装置的壳体的体外血液处理装置中)。例如,泄漏液体可以在装置的基座进行检测,同时壳体位于基座上方例如一米以上的距离处。In one or more embodiments, the pressure sensor may be located in the housing as the control unit, while the fluid-filled pressure line extends out of the housing to a liquid collector where the remote pressure port is located. A shortened electrical connection between the pressure sensor and the control unit would be advantageous, since a longer electrical connection extending from the remote pressure port to the control unit could potentially cause electrical interference (especially at locations remote from the device where leaked liquid is collected). In the extracorporeal blood treatment device of the housing). For example, leaking liquid may be detected at the base of the device while the housing is located above the base at a distance of eg more than one meter.

在一个或多个实施例中,本文所述的体外血液处理装置可以包括由单条流体填充的压力管路连接到压力传感器的本地压力端口的单个远程压力端口。在一个或多个替代实施例中,本文所述的体外血液处理装置可包括连接到一个或多个压力传感器的两个或更多个本地压力端口的两个或更多个远程压力端口,其中每个远程压力端口通过专用的流体填充的压力管路连接到其各自的本地压力端口。在这样的实施例中,远程压力端口可以被布置成检测两个远程压力端口之间的压差,并使用该压差作为判定体外血液处理装置内已发生泄漏的基础。In one or more embodiments, the extracorporeal blood treatment apparatus described herein may include a single remote pressure port connected by a single fluid-filled pressure line to the local pressure port of the pressure sensor. In one or more alternative embodiments, the extracorporeal blood treatment apparatus described herein may comprise two or more remote pressure ports connected to two or more local pressure ports of one or more pressure sensors, wherein Each remote pressure port is connected to its respective local pressure port by a dedicated fluid-filled pressure line. In such an embodiment, the remote pressure ports may be arranged to detect a pressure difference between the two remote pressure ports and use this pressure difference as a basis for determining that a leak has occurred within the extracorporeal blood treatment device.

虽然本文与被配置为使用透析溶液执行透析的体外血液处理装置相关地进行了描述,但在任何体外血液处理装置中也可能遇到类似问题。为了本文讨论的目的,泄漏检测装置可被结合到任何体外血液处理装置,例如,使用用于肾功能的对流置换治疗的置换液、用于治疗性血浆置换(TPE)的血浆、白蛋白或胶体溶液、或与体外血液处理装置相关使用的任何其它已知类型的医疗流体的体外血液处理装置。Although described herein in relation to an extracorporeal blood treatment device configured to perform dialysis using a dialysis solution, similar problems may be encountered in any extracorporeal blood treatment device. For purposes discussed herein, the leak detection device may be incorporated into any extracorporeal blood treatment device, for example, using replacement fluid for convective replacement therapy of renal function, plasma for therapeutic plasma exchange (TPE), albumin, or colloids solution, or any other known type of medical fluid used in connection with extracorporeal blood treatment devices.

在一个方面,本文所述的体外血液处理装置的一个或多个实施例包括:壳体;液体回路,位于所述壳体上或所述壳体中,其中,所述液体回路包括被配置为将血液移动通过所述液体回路以进行体外血液处理的一个或多个泵以及管道;液体收集器,被配置为收集从所述液体回路泄漏的液体;其中,所述从所述液体回路泄漏的液体在重力的作用下到达所述液体收集器;以及压力传感器,包括位于所述壳体上或所述壳体中的本地压力端口、位于所述液体收集器中的选定位置处的远程压力端口以及从所述远程压力端口延伸到所述本地压力端口的压力管路,所述收集器收集的液体积累在所述选定位置上方,其中,所述本地压力端口被定位在所述液体收集器中,使得在所述液体收集器中所述选定位置处收集的液体接触所述远程压力端口,并且其中,所述压力管路被配置为将施加在所述远程压力端口上的压力经由位于所述压力管路中的流体传递到所述本地压力端口。该装置还包括控制单元,该控制单元可操作地连接到所述压力传感器,其中,所述控制单元被配置为:从所述压力传感器接收信号,其中,所述信号指示由所述压力传感器的远程压力端口感测到的压力;以及当由所述远程压力端口感测到的压力达到或超过选定的压力极限时,做出液体从所述液体回路中泄漏的判定。In one aspect, one or more embodiments of the extracorporeal blood treatment apparatus described herein include: a housing; a fluid circuit on or in the housing, wherein the fluid circuit includes a fluid circuit configured to one or more pumps and tubing to move blood through the fluid circuit for extracorporeal blood treatment; a fluid collector configured to collect fluid leaking from the fluid circuit; wherein the fluid leaking from the fluid circuit liquid reaches the liquid collector by gravity; and a pressure sensor including a local pressure port on or in the housing, a remote pressure port at a selected location in the liquid collector port and a pressure line extending from the remote pressure port to the local pressure port, the liquid collected by the collector accumulates above the selected location, wherein the local pressure port is positioned at the liquid collection port in the liquid collector such that the liquid collected at the selected location in the liquid collector contacts the remote pressure port, and wherein the pressure line is configured to transfer the pressure applied to the remote pressure port via Fluid in the pressure line is delivered to the local pressure port. The device also includes a control unit operatively connected to the pressure sensor, wherein the control unit is configured to: receive a signal from the pressure sensor, wherein the signal is indicative of a pressure sensed by the remote pressure port; and a determination that fluid is leaking from the fluid circuit when the pressure sensed by the remote pressure port reaches or exceeds a selected pressure limit.

在本文所述的体外血液处理装置的一个或多个实施例中,压力管路通过流体密封连接器连接到远程压力端口。In one or more embodiments of the extracorporeal blood treatment apparatus described herein, the pressure line is connected to the remote pressure port by a fluid tight connector.

在本文所述的体外血液处理装置的一个或多个实施例中,压力管路通过流体密封连接器连接到本地压力端口。In one or more embodiments of the extracorporeal blood treatment apparatus described herein, the pressure line is connected to the local pressure port by a fluid tight connector.

在本文所述的体外血液处理装置的一个或多个实施例中,所述压力管路中的流体实质上由一种或多种气体组成。In one or more embodiments of the extracorporeal blood treatment device described herein, the fluid in the pressure line consists essentially of one or more gases.

在本文所述的体外血液处理装置的一个或多个实施例中,所述压力管路中的流体实质上由一种或多种液体组成。In one or more embodiments of the extracorporeal blood treatment apparatus described herein, the fluid in the pressure line consists essentially of one or more liquids.

在本文所述的体外血液处理装置的一个或多个实施例中,所述压力传感器包括:被配置为在第二选定位置处测量大气压力的第二远程压力端口;以及从所述第二远程压力端口延伸到压力传感器的第二本地压力端口的第二压力管路,其中,所述第二压力管路被配置为将施加在第二远程压力端口上的压力通过位于所述第二压力管路中的流体传递到第二本地压力端口;并且其中,所述控制单元被配置为当所述远程压力端口和所述第二远程压力端口感测到的压力的差达到或者超过一选定值时,做出液体从所述液体回路中泄漏的判定。在一个或多个实施例中,第二选定位置被定位在相对于所述第二本地压力端口的选定高度,并且其中,位于所述液体收集器的所述选定位置处的远程压力端口也位于相对于与其连接的本地压力端口的所述选定高度。在一个或多个实施例中,第二压力管路中的流体实质上由一种或多种气体组成。在一个或多个实施例中,第二压力管路中的流体实质上由一种或多种液体组成。In one or more embodiments of the extracorporeal blood treatment apparatus described herein, the pressure sensor comprises: a second remote pressure port configured to measure atmospheric pressure at a second selected location; The remote pressure port extends to a second pressure line of a second local pressure port of the pressure sensor, wherein the second pressure line is configured to pass the pressure applied on the second remote pressure port through the pressure sensor located at the second pressure port. fluid in the line is delivered to a second local pressure port; and wherein the control unit is configured to sense a pressure difference between the remote pressure port and the second remote pressure port when the difference in pressure reaches or exceeds a selected value, a determination is made that liquid leaks from the liquid circuit. In one or more embodiments, a second selected location is positioned at a selected height relative to said second local pressure port, and wherein the remote pressure at said selected location of said liquid collector The port is also located at said selected height relative to the local pressure port to which it is connected. In one or more embodiments, the fluid in the second pressure line consists essentially of one or more gases. In one or more embodiments, the fluid in the second pressure line consists essentially of one or more liquids.

在本文所述的体外血液处理装置的一个或多个实施例中,所述控制单元可操作地连接到所述液体回路的一个或多个泵中的泵,并且其中,所述控制单元被配置为当所述控制单元判定所述液体回路泄漏时停止该泵的操作。In one or more embodiments of the extracorporeal blood treatment apparatus described herein, the control unit is operatively connected to a pump of the one or more pumps of the fluid circuit, and wherein the control unit is configured To stop the operation of the pump when the control unit determines that the liquid circuit is leaking.

在第二方面,在如本文所述的检测体外血液处理装置中的泄漏的方法的一个或多个实施例可以包括:通过位于壳体上或壳体中的液体回路来泵送液体,所述液体回路包括被配置为执行体外血液处理的一个或多个泵以及管道;将从所述液体回路泄漏的液体收集在位于所述壳体下方的液体收集器中;检测由所述液体收集器中收集的液体施加在压力传感器的远程压力端口上的压力,其中,所述压力传感器位于所述壳体上或所述壳体中,并且其中,所述远程压力端口位于所述液体收集器中的选定位置;使用从所述远程压力端口延伸到所述压力传感器的本地压力端口的压力管路将在所述远程压力端口上检测到的压力传递到所述本地压力端口,其中,所述压力管路将压力从所述远程压力端口通过位于所述压力管路中的流体传递到所述本地压力端口;以及当由所述远程压力端口感测到的压力达到或超过选定的压力极限时,做出液体从所述液体回路中泄漏的判定。In a second aspect, one or more embodiments of the method of detecting a leak in an extracorporeal blood treatment apparatus as described herein may include pumping a fluid through a fluid circuit located on or in the housing, the The liquid circuit includes one or more pumps and piping configured to perform extracorporeal blood treatment; collecting liquid leaking from the liquid circuit in a liquid collector located below the housing; detecting pressure exerted by collected liquid on a remote pressure port of a pressure sensor, wherein the pressure sensor is located on or in the housing, and wherein the remote pressure port is located in the liquid collector selected location; transmitting the pressure detected at the remote pressure port to the local pressure port using a pressure line extending from the remote pressure port to the local pressure port of the pressure sensor, wherein the pressure a line delivering pressure from the remote pressure port to the local pressure port through fluid located in the pressure line; and when the pressure sensed by the remote pressure port reaches or exceeds a selected pressure limit , a determination is made that liquid leaks from the liquid circuit.

在第二方面,在如本文所述的检测体外血液处理装置中的泄漏的方法的一个或多个实施例可以包括:通过位于壳体上或壳体中的液体回路来泵送液体,所述液体回路包括被配置为执行体外血液处理的一个或多个泵以及管道;将从所述液体回路泄漏的液体收集在位于所述壳体下方的液体收集器中;检测由所述液体收集器中收集的液体施加在第一远程压力端口上的压力,其中,所述第一远程压力端口位于所述液体收集器中的第一选定位置处,并且其中,所述收集器所收集的液体积累在所述第一远程压力端口上方;使用从所述第一远程压力端口延伸到位于所述壳体上或所述壳体中的压力传感器的第一本地压力端口的第一压力管路将在所述第一远程压力端口上检测到的压力传递到所述第一本地压力端口,其中,所述第一压力管路将压力从所述第一远程压力端口经由位于所述第一压力管路中的流体传递到所述第一本地压力端口;检测作用于第二远程压力端口上的大气压力;使用从所述第二远程压力端口延伸到所述压力传感器的第二本地压力端口的第二压力管路将在所述第二远程压力端口上检测到的大气压力传递到所述第二本地压力端口,其中,所述第二压力管路将压力从所述第二远程压力端口经由位于所述第二压力管路中的流体传递到所述第二本地压力端口;以及当由所述第一远程压力端口和所述第二远程压力端口感测到的压力的差达到或超过一选定值时,做出液体从所述液体回路中泄漏的判定。在一个或多个实施例中,所述第二远程压力端口被定位在相对于所述第二本地压力端口的选定高度,并且其中,所述第一远程压力端口也位于相对于所述第一本地压力端口的所述选定高度。In a second aspect, one or more embodiments of the method of detecting a leak in an extracorporeal blood treatment apparatus as described herein may include pumping a fluid through a fluid circuit located on or in the housing, the The liquid circuit includes one or more pumps and piping configured to perform extracorporeal blood treatment; collecting liquid leaking from the liquid circuit in a liquid collector located below the housing; detecting pressure exerted by collected liquid on a first remote pressure port, wherein the first remote pressure port is located at a first selected location in the liquid collector, and wherein collected liquid in the collector accumulates above the first remote pressure port; using a first pressure line extending from the first remote pressure port to a first local pressure port of a pressure sensor located on or in the housing will be at Pressure sensed on the first remote pressure port is communicated to the first local pressure port, wherein the first pressure line transfers pressure from the first remote pressure port via a transfer the fluid in the first local pressure port; detect the atmospheric pressure acting on the second remote pressure port; use the second local pressure port extending from the second remote pressure port to the pressure transducer A pressure line communicates atmospheric pressure sensed at the second remote pressure port to the second local pressure port, wherein the second pressure line transmits pressure from the second remote pressure port via the transfer of fluid in the second pressure line to the second local pressure port; and when the difference in pressure sensed by the first remote pressure port and the second remote pressure port reaches or exceeds a selected value, a determination is made that liquid leaks from the liquid circuit. In one or more embodiments, the second remote pressure port is positioned at a selected height relative to the second local pressure port, and wherein the first remote pressure port is also positioned relative to the first The selected height of a local pressure port.

在本文所描述的方法的一个或多个实施例中,所述压力管路中的流体实质上由一种或多种气体组成。In one or more embodiments of the methods described herein, the fluid in the pressure line consists essentially of one or more gases.

在本文所述方法的一个或多个实施例中,所述方法还包括在判定液体从所述液体回路中泄漏后,停止所述液体回路中的一个或多个泵中的泵。In one or more embodiments of the methods described herein, the method further comprises stopping a pump of the one or more pumps in the liquid circuit after determining that liquid has leaked from the liquid circuit.

除非上下文另有明确规定,如本文和所附权利要求书中使用的单数形式“一”、“一个”和“该”包括复数对象。因此,例如,提到“一”或“该”组件可以包括一个或多个组件以及本领域技术人员已知的其等同物。此外,术语“和/或”是指一个或所有列出的元件,或者所列出元件中的任何两个或更多个的组合。As used herein and in the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to "a" or "the" component may include one or more components and equivalents thereof known to those skilled in the art. In addition, the term "and/or" refers to one or all of the listed elements, or a combination of any two or more of the listed elements.

应该注意的是,出现在说明书中的术语“包括”及其变型不具有限制意义。而且,“一”、“一个”、“该”、“至少一个”和“一个或多个”在本文可互换使用。It should be noted that the term "comprising" and its variants appearing in the specification do not have a restrictive meaning. Also, "a", "an", "the", "at least one" and "one or more" are used interchangeably herein.

以上内容并非意图描述本文中所描述的体外血液处理装置和方法的每个实施例或每种实现方式。相反,并且基于所附附图通过参考示例性实施例和权利要求书的以下说明,本发明的更完整的理解将变得显而易见和易于领会。The above summary is not intended to describe each embodiment or every implementation of the extracorporeal blood treatment apparatus and methods described herein. Rather, a more complete understanding of the invention will become apparent and appreciated by reference to the following description of the exemplary embodiments and claims based on the accompanying drawings.

附图说明Description of drawings

图1示出体外血液处理装置的一个示例性实施例,其配置为使用如本文所描述的基于压力的泄漏检测来检测泄漏。Figure 1 illustrates an exemplary embodiment of an extracorporeal blood treatment device configured to detect leaks using pressure-based leak detection as described herein.

图2是包括如本文所描述的液体回路的体外血液处理装置的一个示例性实施例的示意图。Figure 2 is a schematic illustration of an exemplary embodiment of an extracorporeal blood treatment apparatus including a fluid circuit as described herein.

图3是如本文所描述的体外血液处理装置的另一个示例性实施例的示意图。Figure 3 is a schematic illustration of another exemplary embodiment of an extracorporeal blood treatment apparatus as described herein.

具体实施方式Detailed ways

在示例性实施例的以下描述中,参考了形成本文的一部分的附图,并且在附图中通过示例的方式示出了具体实施例。应当理解的是,可以利用其它实施例,且可以在不脱离本发明范围的情况下进行结构变化。In the following description of the exemplary embodiments, reference is made to the accompanying drawings which form a part hereof, and in which is shown by way of example specific embodiments. It is to be understood that other embodiments may be utilized and structural changes may be made without departing from the scope of the present invention.

体外血液处理装置的一个示例性实施例示于图1。在一个或多个实施例中,体外血液处理装置1是用于治疗肾功能不全的透析机,其可以执行一种或多种以下处理:血液透析、单纯超滤、血液滤过、血液透析滤过、治疗性血浆置换等。An exemplary embodiment of an extracorporeal blood treatment device is shown in FIG. 1 . In one or more embodiments, the extracorporeal blood treatment device 1 is a dialysis machine for treating renal insufficiency, which can perform one or more of the following treatments: hemodialysis, simple ultrafiltration, hemofiltration, hemodiafiltration over, therapeutic plasma exchange, etc.

在图1所示的实施例中,装置1特别适用于急性肾功能衰竭的强化治疗,并包括血液处理设备2(例如,透析器过滤器)和能够将流体(例如,血液、透析溶液等)传送到血液处理设备2的流体分配回路3。为了使附图简单和清楚,图1中仅示出用于流体分配回路3的支持件。In the embodiment shown in FIG. 1 , the device 1 is particularly suitable for intensive treatment of acute renal failure and comprises a blood treatment device 2 (eg, a dialyzer filter) and is capable of transferring fluid (eg, blood, dialysis solution, etc.) to the fluid distribution circuit 3 of the blood treatment apparatus 2 . In order to keep the drawing simple and clear, only the support for the fluid distribution circuit 3 is shown in FIG. 1 .

体外血液处理装置1还包括用于在流体分配回路3内循环流体的一个或多个泵4。流体分配回路3可以被配置为将血液移动到病人并从病人移动血液,以及移动由储液器6提供和/或被传送到储液器6的流体,在所示的实施例中,该储液器6悬挂于体外血液处理装置1的壳体12的底端13。所示的储液器6为袋子的形式,然而也可使用用于在内部包含流体的任何其它合适的容器来代替袋子。The extracorporeal blood treatment device 1 also comprises one or more pumps 4 for circulating fluid within the fluid distribution circuit 3 . Fluid distribution circuit 3 may be configured to move blood to and from a patient, as well as fluid provided by and/or delivered to reservoir 6, which in the illustrated embodiment is The liquid container 6 is suspended from the bottom end 13 of the housing 12 of the extracorporeal blood treatment device 1 . The reservoir 6 is shown in the form of a bag, however any other suitable container for containing fluid inside may be used instead of a bag.

图1中所示的体外血液处理装置1还包括基座14,壳体12由立柱16支撑在该基座14上方。基座14包括液体收集器20,其被设于壳体12的底端13下方。收集器20被成形为收集从位于基座14上方的体外血液处理装置1的壳体12之中或之上的液体回路泄漏的液体。收集器20的表面成形和或成一角度为将液体收集在收集器20的一个区域,而不管液体在哪个位置首先接触收集器20。在图1所示的实施例中,例如,收集器20包括被设计成将液体朝向收集区23引导的表面,该收集区23比收集器20的其余部分位置低。The extracorporeal blood treatment device 1 shown in FIG. 1 also includes a base 14 on which the housing 12 is supported by a column 16 . The base 14 includes a liquid collector 20 disposed below the bottom end 13 of the housing 12 . The collector 20 is shaped to collect liquid leaking from a liquid circuit in or on the housing 12 of the extracorporeal blood treatment device 1 located above the base 14 . The surface of the collector 20 is shaped and or angled to collect liquid in one area of the collector 20 regardless of where the liquid first contacts the collector 20 . In the embodiment shown in FIG. 1 , for example, the collector 20 includes a surface designed to direct the liquid towards a collection area 23 which is lower than the rest of the collector 20 .

从图1所示的体外血液处理装置1的实施例中还可以看到远程压力端口22,如本文所描述的,远程压力端口22与压力传感器相结合使用,以检测体外血液处理装置1的泄漏。虽然在图1的实施例中示出了两个远程压力端口22,但在一个或多个其它实施例中,如本文将描述的,例如可使用少至一个的远程压力端口来执行这里描述的装置的泄漏检测功能。Also visible in the embodiment of the extracorporeal blood treatment apparatus 1 shown in FIG. 1 is the remote pressure port 22, which is used in combination with a pressure sensor to detect leakage of the extracorporeal blood treatment apparatus 1 as described herein. . While two remote pressure ports 22 are shown in the embodiment of FIG. 1 , in one or more other embodiments, as will be described herein, for example, as few as one remote pressure port may be used to perform the methods described herein. The leak detection function of the device.

图2是体外血液处理装置的一个示例性实施例的示意图,其包括如本文所述的液体回路。所描绘的液体回路的一个部分包括血液泵4a,该血液泵4a被配置为移动使用动脉管路7从病人P移出的血液,并例如使用血液泵4a将其传送到血液处理设备2。图2所示的液体回路还包括用于将血液从过滤器2返回到病人P的静脉管路8。图2所示的液体回路的另一部分包括透析液泵4b,其用于经由传送管路9将透析液从储液器6a传送到血液处理设备2中,并经由废液管路10将用过的透析液从血液处理设备2移出并将其传送到储液器6b中。Figure 2 is a schematic diagram of an exemplary embodiment of an extracorporeal blood treatment apparatus including a fluid circuit as described herein. One part of the depicted fluid circuit comprises a blood pump 4a configured to move blood removed from the patient P using the arterial line 7 and convey it to the blood treatment apparatus 2, eg using the blood pump 4a. The fluid circuit shown in FIG. 2 also includes a venous line 8 for returning blood from the filter 2 to the patient P. As shown in FIG. Another part of the liquid circuit shown in FIG. The dialysate is removed from the blood treatment device 2 and transferred to the reservoir 6b.

在图2的体外血液处理装置的示例性实施例中还示出收集器20,其足够大并且适当地定位以收集从体外血液处理装置1之中或之上的液体回路泄漏的液体。优选地,收集器20包括倾斜的或成角度的表面,使得落入收集器20中的液体被送往并收集在远程压力端口22被定位的位置上方。远程压力端口22通过压力管路24连接到压力传感器28上的本地压力端口26。Also shown in the exemplary embodiment of the extracorporeal blood treatment device 20 is a collector 20 which is sufficiently large and suitably positioned to collect liquid leaking from a liquid circuit in or on the extracorporeal blood treatment device 1 . Preferably, collector 20 includes a sloped or angled surface such that liquid falling into collector 20 is sent to and collected above where remote pressure port 22 is located. The remote pressure port 22 is connected to a local pressure port 26 on a pressure sensor 28 by a pressure line 24 .

收集在收集器20中的液体在远程压力端口22上施加压力,并且该压力通过流体填充的压力管路24传递到压力传感器28上的本地压力端口26。如本文中所讨论的,使用流体填充的压力管路24将收集器20中收集的液体施加到远程压力端口22上的压力传递到压力传感器28上的本地压力端口26,这样可以减少或消除在与流体填充的压力管路24相同的路径上延伸的电连接会引起的电气干扰的潜在可能。Liquid collected in collector 20 exerts pressure on remote pressure port 22 and this pressure is communicated through fluid-filled pressure line 24 to local pressure port 26 on pressure sensor 28 . As discussed herein, the use of fluid-filled pressure line 24 to transmit the pressure applied to remote pressure port 22 by liquid collected in collector 20 to local pressure port 26 on pressure sensor 28 reduces or eliminates The potential for electrical interference would arise from electrical connections extending on the same path as the fluid-filled pressure line 24 .

在一个或多个实施例中,远程压力端口22可以包括膜或其它结构,从而防止收集在收集器20中的液体以允许其混入或进入流体填充的压力管路24的方式进入远程压力端口22。In one or more embodiments, remote pressure port 22 may include a membrane or other structure to prevent liquid collected in collector 20 from entering remote pressure port 22 in a manner that would allow it to mix or enter fluid-filled pressure line 24 .

在本文所述的体外血液处理装置的一个或多个实施例中,用于将压力从远程压力端口22传递到压力传感器28的本地压力端口26的流体填充的压力管路24可经由连接器23连接到远程压力端口22,并经由连接器27连接到压力传感器28上的本地压力端口26。连接器23和27可以相同或不同,并且可以采取各种形式,例如,鲁尔旋转锁连接、卡口式安装、软管夹和接头、或在压力管路24中的流体与远程压力端口22处泄漏的液体之间以及在压力管路24中的流体与本地压力端口26之间传送所需压力的任何其它合适的连接。In one or more embodiments of the extracorporeal blood treatment apparatus described herein, a fluid-filled pressure line 24 for communicating pressure from a remote pressure port 22 to a local pressure port 26 of a pressure sensor 28 may be provided via a connector 23 Connects to remote pressure port 22 and connects via connector 27 to local pressure port 26 on pressure sensor 28 . Connectors 23 and 27 may be the same or different, and may take various forms, such as a Luer twist lock connection, a bayonet fit, a hose clamp and fitting, or a fluid connection in pressure line 24 to remote pressure port 22 Any other suitable connection that transmits the required pressure between the leaking liquid and between the fluid in the pressure line 24 and the local pressure port 26.

在本文所述的体外血液处理装置的一个或多个实施例中,压力管路24中的流体可以是能够以可接受的精度将施加在远程压力端口22上的压力传输到压力传感器28上的本地压力端口26的任何合适的流体。一些在流体填充的压力管路24中使用的潜在合适的流体的示例可以包括例如空气、氮气、盐溶液、凝胶、水等。在一个或多个实施例中,本文中所描述的体外血液处理装置中使用的流体填充的压力管路可仅填充气体(例如,压力管路中的流体实质由一种或多种气体构成,如空气、氮气等),或者它们可以仅填充有液体(例如,压力管路中的流体可实质上由一种或多种液体构成)。In one or more embodiments of the extracorporeal blood treatment apparatus described herein, the fluid in pressure line 24 may be of a type capable of transmitting the pressure applied at remote pressure port 22 to pressure transducer 28 with acceptable accuracy. Any suitable fluid from local pressure port 26. Some examples of potentially suitable fluids for use in fluid-filled pressure line 24 may include, for example, air, nitrogen, saline, gel, water, and the like. In one or more embodiments, the fluid-filled pressure lines used in the extracorporeal blood treatment devices described herein may only be filled with gas (e.g., the fluid in the pressure line consists essentially of one or more gases, such as air, nitrogen, etc.), or they may be filled with liquids only (eg, the fluid in the pressure line may consist essentially of one or more liquids).

与图2中的体外血液处理装置1的示例性实施例相关地描述的另一部件是控制单元30。在所描述的实施例中,血液泵4a和透析溶液泵4b两者可操作地连接到控制单元30。另外,通过流体填充的压力管路24连接到远程压力端口22的压力传感器28也可操作地连接到控制单元30。Another component described in connection with the exemplary embodiment of the extracorporeal blood treatment device 1 in FIG. 2 is the control unit 30 . In the described embodiment, both the blood pump 4 a and the dialysis solution pump 4 b are operatively connected to the control unit 30 . Additionally, a pressure sensor 28 connected to the remote pressure port 22 through a fluid-filled pressure line 24 is also operatively connected to the control unit 30 .

控制单元30被配置为从压力传感器28接收信号。来自压力传感器28的信号指示在通过流体填充的压力管路24连接到压力传感器28上的本地压力端口26的远程压力端口22处感测到的压力。如果由控制单元30从压力传感器28接收的信号指示远程压力端口22处感测的压力超出所选择的极限,则可以判定液体从体外血液处理装置1中的液体回路泄漏。The control unit 30 is configured to receive signals from the pressure sensor 28 . The signal from the pressure sensor 28 is indicative of the pressure sensed at the remote pressure port 22 connected to a local pressure port 26 on the pressure sensor 28 by a fluid-filled pressure line 24 . If the signal received by the control unit 30 from the pressure sensor 28 indicates that the pressure sensed at the remote pressure port 22 exceeds a selected limit, it may be determined that liquid is leaking from the liquid circuit in the extracorporeal blood treatment apparatus 1 .

所选择的极限可以是收集器20中的液体量的函数,该液体量与远程压力端口22上方的收集器20中的液体高度相关。具体地,远程压力端口22处的压力(P)的函数为P=ρ*g*h,其中ρ=液体的密度,g=重力加速度,且h=远程压力端口22上方液体的高度。The selected limit may be a function of the amount of liquid in the collector 20 relative to the height of the liquid in the collector 20 above the remote pressure port 22 . Specifically, the pressure (P) at the remote pressure port 22 is a function of P=ρ*g*h, where ρ=density of the liquid, g=acceleration of gravity, and h=height of the liquid above the remote pressure port 22.

如果做出了该判定,则体外血液处理装置1可以被配置为以报警或其它信号的形式向操作者提供指示,并且在一个或多个实施例中,还可以导致可操作地连接到控制单元的一个或多个泵的操作终止。此外,如果体外血液处理装置包括可以选择性地闭合的阀、夹子等,则对于体外血液处理装置内发生泄漏的判定还会致使控制单元启动阀、夹子等的闭合(如果这样的动作是必要的)。If this determination is made, the extracorporeal blood treatment apparatus 1 may be configured to provide an indication to the operator in the form of an alarm or other signal and, in one or more embodiments, may also result in an operative connection to the control unit Operation of one or more pumps is terminated. In addition, if the extracorporeal blood treatment device includes a valve, clamp, etc. ).

在本文所描述的体外血液处理装置中使用的控制单元可以以任何合适的形式设置,并且可以例如包括存储器和控制器。该控制器可以例如为一个或多个微处理器、专用集成电路(ASIC)状态机等形式。控制单元可以包括一个或多个被配置为允许用户操作装置的任何合适的输入设备(例如,键盘、触摸屏、鼠标、轨迹球等),以及被配置为将信息传达给用户的显示设备(例如,监控器(其可以是也可以不是触摸屏)、指示灯等)。The control unit used in the extracorporeal blood treatment apparatus described herein may be arranged in any suitable form and may eg comprise a memory and a controller. The controller may, for example, be in the form of one or more microprocessors, application specific integrated circuit (ASIC) state machines, or the like. The control unit may include one or more any suitable input device (e.g., keyboard, touch screen, mouse, trackball, etc.) configured to allow a user to operate the device, and a display device (e.g., monitor (which may or may not be a touch screen), indicator lights, etc.).

体外血液处理装置101的另一可选示例性实施例示于图3中。在图3的示意图中所示出的形成体外血液处理装置101的一部分的部件中有泵104、压力传感器128以及控制单元130,所有这些部件都被描述为位于体外血液处理装置101的壳体112内。图3中示出的体外血液处理装置101还包括液体收集器120,该液体收集器120被定位且尺寸被制作为收集从体外血液处理装置101内的液体回路泄漏的液体。Another alternative exemplary embodiment of an extracorporeal blood treatment device 101 is shown in FIG. 3 . Among the components forming part of the extracorporeal blood treatment device 101 shown in the schematic diagram of FIG. Inside. The extracorporeal blood treatment device 101 shown in FIG. 3 also includes a liquid collector 120 positioned and dimensioned to collect liquid leaking from the fluid circuit within the extracorporeal blood treatment device 101 .

压力传感器128包括两个本地压力端口126a和126b。第一远程压力端口122a通过流体填充的压力管路124a连接到压力传感器128上的本地压力端口126a,而第二远程压力端口122b通过第二流体填充的压力管路124b连接到压力传感器128的本地压力端口126b。Pressure sensor 128 includes two local pressure ports 126a and 126b. The first remote pressure port 122a is connected to a local pressure port 126a on the pressure sensor 128 through a fluid-filled pressure line 124a, while the second remote pressure port 122b is connected to the local pressure port 126a on the pressure sensor 128 through a second fluid-filled pressure line 124b. Pressure port 126b.

第一远程压力端口122a被定位在液体收集器122中以检测由液体收集器120中收集的液体施加在远程压力端口122a上的压力。第二远程压力端口122b对于大气压力是开放的。在一个或多个实施例中,第二远程压力端口126b相对于本地压力端口126a和126b被定位在与第一远程压力端口122a相同的高度h上。这样做允许系统既校正大气压力变化,又消除由流体填充的管路124a和124b中的流体产生的压头。应当指出的是,本文所用的相对位置术语,例如“上方”、“下方”和“高度”是沿着重力的方向测得的。The first remote pressure port 122a is positioned in the liquid collector 122 to detect the pressure exerted on the remote pressure port 122a by the liquid collected in the liquid collector 120 . The second remote pressure port 122b is open to atmospheric pressure. In one or more embodiments, the second remote pressure port 126b is positioned at the same height h as the first remote pressure port 122a relative to the local pressure ports 126a and 126b. Doing so allows the system to both correct for atmospheric pressure changes and eliminate the pressure head created by the fluid in fluid-filled lines 124a and 124b. It should be noted that relative positional terms used herein, such as "above", "below" and "height" are measured along the direction of gravity.

虽然在所描述的实施例中本地压力端口126a和126b是单个压力传感器128的一部分,但在一个或多个替代实施例中,每个本地压力端口可以被连接到单独且独立的压力传感器,其中每个独立的压力传感器可操作地连接到控制单元130。Although in the depicted embodiment local pressure ports 126a and 126b are part of a single pressure sensor 128, in one or more alternative embodiments, each local pressure port may be connected to a separate and independent pressure sensor, wherein Each individual pressure sensor is operatively connected to the control unit 130 .

虽然与图1-图3所示的装置相关地描述了检测体外血液处理装置中的泄漏的方法,但本文描述的检测体外血液处理装置中的泄漏的方法的一个或多个实施例可以包括通过位于体外血液处理装置的壳体上或位于体外血液处理装置的壳体中的液体回路泵送液体。如本文所述的,该液体回路可包括被配置为执行体外血液处理的一个或多个泵和管道。从液体回路泄漏的液体可被收集在位于体外血液处理装置的壳体下方的液体收集器中。Although the method of detecting a leak in an extracorporeal blood processing device has been described in relation to the device shown in FIGS. 1-3 , one or more embodiments of the method of detecting a leak in an extracorporeal blood processing device described herein may include A liquid circuit located on or in the housing of the extracorporeal blood treatment device pumps liquid. As described herein, the fluid circuit may include one or more pumps and tubing configured to perform extracorporeal blood treatment. Liquid leaking from the liquid circuit may be collected in a liquid collector located below the housing of the extracorporeal blood treatment device.

在一个或多个实施例中,这些方法可以包括检测通过收集在液体收集器中的液体施加到压力传感器的远程压力端口上的压力。该压力传感器位于壳体上或壳体中,且远程压力端口位于液体收集器中的选定位置。施加在远程压力端口上的压力使用从远程压力端口延伸到本地压力端口的压力管路被传递到压力传感器的本地压力端口。压力管路将压力从远程压力端口通过位于压力管路中的流体而传递到本地压力端口。In one or more embodiments, the methods may include detecting the pressure applied to the remote pressure port of the pressure sensor by liquid collected in the liquid collector. The pressure sensor is located on or in the housing and the remote pressure port is located at a selected location in the liquid collector. The pressure applied on the remote pressure port is transferred to the local pressure port of the pressure sensor using a pressure line extending from the remote pressure port to the local pressure port. A pressure line transfers pressure from the remote pressure port to the local pressure port through fluid located in the pressure line.

当收集在泄漏收集器中的液体施加在远程压力端口上的压力达到或超过选定的压力极限时,该方法进一步包括判定液体从液体回路中泄漏出。The method further includes determining that liquid has leaked from the liquid circuit when the pressure exerted by the liquid collected in the leak collector on the remote pressure port reaches or exceeds a selected pressure limit.

在如本文中所描述的检测泄漏的方法的一个或多个替代实施例中,检测由收集在液体收集器中的泄漏液体所施加的压力可包括检测由液体收集器中收集的液体施加在压力传感器的第一远程压力端口上的压力。压力传感器位于体外血液处理装置的壳体上或体外血液处理装置的壳体中。第一远程压力端口位于液体收集器中的第一选定位置。在第一远程压力端口处检测到的压力使用从第一远程压力端口延伸到第一本地压力端口的第一压力管路被传送到压力传感器的第一本地压力端口。第一压力管路将压力从第一远程压力端口通过位于第一压力管路中的流体而传送到第一本地压力端口。In one or more alternative embodiments of the method of detecting a leak as described herein, detecting the pressure exerted by the leaking liquid collected in the liquid collector may include detecting the pressure exerted by the liquid collected in the liquid collector. Pressure on the sensor's first remote pressure port. The pressure sensor is located on or in the housing of the extracorporeal blood treatment device. A first remote pressure port is located at a first selected location in the liquid collector. The pressure detected at the first remote pressure port is communicated to the first local pressure port of the pressure sensor using a first pressure line extending from the first remote pressure port to the first local pressure port. The first pressure line communicates pressure from the first remote pressure port to the first local pressure port through fluid located in the first pressure line.

此方法还可以包括检测施加在第二远程压力端口上的大气压力,该第二远程压力端口通过第二流体填充的管路连接到压力传感器的第二本地压力端口。结果,施加在第一远程压力传感器上的压力可被调整为考虑大气压的变化。在一个或多个实施例中,第二远程压力端口可以相对于压力传感器上的本地压力端口被定位在与第一压力端口相同的高度。结果,施加在第一远程压力端口上的压力也可以针对压头进行调整,该压头是由于将第一和第二远程压力端口连接到压力传感器的流体填充的压力管路中的流体产生的。The method may also include sensing atmospheric pressure applied to a second remote pressure port connected to a second local pressure port of the pressure sensor by a second fluid-filled line. As a result, the pressure applied to the first remote pressure sensor can be adjusted to account for changes in atmospheric pressure. In one or more embodiments, the second remote pressure port may be positioned at the same elevation as the first pressure port relative to the local pressure port on the pressure sensor. As a result, the pressure applied to the first remote pressure port can also be adjusted for the head pressure due to fluid in the fluid-filled pressure line connecting the first and second remote pressure ports to the pressure sensor .

涉及这样的第一和第二远程压力端口上的压力检测的方法包括:当第一远程压力端口和第二远程压力端口感测到的压力的差达到或者超过一选定值时,判定液体从液体回路中泄漏。A method involving pressure sensing on such first and second remote pressure ports includes determining that the liquid is coming from Leak in liquid circuit.

在如本文中所描述的检测体外血液处理装置的液体回路中的泄漏的方法的一个或多个实施例中,用于从远程压力端口向本地端口压力传递压力的压力管路中的流体实质上由一种或者多种气体组成。In one or more embodiments of the method of detecting a leak in a fluid circuit of an extracorporeal blood processing apparatus as described herein, the fluid in the pressure line for pressure transfer from the remote pressure port to the local port is substantially Composed of one or more gases.

在如本文中所描述的检测体外血液处理装置的液体回路中的泄漏的方法的一个或多个实施例中,用于从远程压力端口向本地压力端口传递压力的压力管路中的流体实质上由一种或者多种液体组成。In one or more embodiments of the method of detecting a leak in a fluid circuit of an extracorporeal blood processing apparatus as described herein, the fluid in the pressure line used to transfer pressure from the remote pressure port to the local pressure port is substantially Consists of one or more liquids.

在如本文中所描述的检测体外血液处理装置的液体回路中的泄漏的方法的一个或多个实施例中,该方法可以包括:在判定液体从液体回路泄漏时,停止液体回路中的一个或多个泵中的泵。In one or more embodiments of the method of detecting a leak in a fluid circuit of an extracorporeal blood treatment apparatus as described herein, the method may include: upon determining that fluid has leaked from the fluid circuit, stopping one or A pump of multiple pumps.

本文指出的专利、专利文献以及出版物的完整公开内容均通过引用整体并入,如同它们中的每个分别并入本文一样。The complete disclosures of the patents, patent documents, and publications identified herein are hereby incorporated by reference in their entirety, as if each were individually incorporated.

已对血液处理装置及使用其的方法的示意性实施例进行了讨论,并参考了可能的变化。本发明中的这些和其它变化和修改在不脱离本发明的范围的情况下对于本领域技术人员而言将是显而易见的,并且应当理解,本发明并不限于本文所阐述的示例性实施例。因此,本发明仅由以下提供的权利要求书及其等同物来限定。Illustrative embodiments of blood processing apparatus and methods of using same have been discussed with reference to possible variations. These and other changes and modifications in the invention will be apparent to those skilled in the art without departing from the scope of the invention, and it should be understood that this invention is not limited to the exemplary embodiments set forth herein. Accordingly, the invention is to be limited only by the claims provided below and their equivalents.

Claims (15)

1.一种体外血液处理装置,包括:1. An extracorporeal blood treatment device, comprising: 壳体;case; 液体回路,位于所述壳体上或所述壳体中,其中,所述液体回路包括被配置为将血液移动通过所述液体回路以进行体外血液处理的一个或多个泵以及管道;a fluid circuit on or in the housing, wherein the fluid circuit includes one or more pumps and tubing configured to move blood through the fluid circuit for extracorporeal blood treatment; 液体收集器,被配置为收集从所述液体回路泄漏的液体;其中,所述从所述液体回路泄漏的液体在重力的作用下到达所述液体收集器;a liquid collector configured to collect liquid leaking from the liquid circuit; wherein the liquid leaking from the liquid circuit reaches the liquid collector under the action of gravity; 压力传感器,包括位于所述壳体上或所述壳体中的本地压力端口、位于所述液体收集器中的选定位置处的远程压力端口以及从所述远程压力端口延伸到所述本地压力端口的压力管路,所述收集器收集的液体积累在所述选定位置上方,其中,所述本地压力端口被定位在所述液体收集器中,使得在所述液体收集器中所述选定位置处收集的液体接触所述远程压力端口,并且其中,所述压力管路被配置为将施加在所述远程压力端口上的压力经由位于所述压力管路中的流体传递到所述本地压力端口;以及a pressure sensor comprising a local pressure port on or in the housing, a remote pressure port at a selected location in the liquid collector, and a pressure sensor extending from the remote pressure port to the local pressure port. The pressure line of the port where the liquid collected by the collector accumulates above the selected location, wherein the local pressure port is positioned in the liquid collector such that the selected location in the liquid collector Liquid collected at the location contacts the remote pressure port, and wherein the pressure line is configured to transfer pressure exerted on the remote pressure port to the local pressure line via fluid located in the pressure line pressure ports; and 控制单元,可操作地连接到所述压力传感器,其中,所述控制单元被配置为:a control unit operatively connected to the pressure sensor, wherein the control unit is configured to: 从所述压力传感器接收信号,其中,所述信号指示由所述压力传感器的远程压力端口感测到的压力;以及receiving a signal from the pressure sensor, wherein the signal is indicative of pressure sensed by a remote pressure port of the pressure sensor; and 当由所述远程压力端口感测到的压力达到或超过选定的压力极限时,做出液体从所述液体回路中泄漏的判定。A determination is made that fluid is leaking from the fluid circuit when the pressure sensed by the remote pressure port reaches or exceeds a selected pressure limit. 2.根据权利要求1的装置,其中,所述压力管路通过流体密封连接器被连接到所述远程压力端口。2. The apparatus of claim 1, wherein the pressure line is connected to the remote pressure port by a fluid tight connector. 3.根据权利要求1或2所述的装置,其中,所述压力管路通过流体密封连接器被连接到所述本地压力端口。3. Apparatus according to claim 1 or 2, wherein the pressure line is connected to the local pressure port by a fluid tight connector. 4.根据权利要求1至3中任一项所述的装置,其中,所述压力管路中的流体实质上由一种或多种气体组成。4. Apparatus according to any one of claims 1 to 3, wherein the fluid in the pressure line consists essentially of one or more gases. 5.根据权利要求1至3中任一项所述的装置,其中,所述压力管路中的流体实质上由一种或多种液体组成。5. Apparatus according to any one of claims 1 to 3, wherein the fluid in the pressure line consists essentially of one or more liquids. 6.根据权利要求1至5中任一项所述的装置,其中,所述压力传感器包括:6. Apparatus according to any one of claims 1 to 5, wherein the pressure sensor comprises: 第二远程压力端口,被配置为在第二选定位置处测量大气压力;以及a second remote pressure port configured to measure barometric pressure at a second selected location; and 第二压力管路,从所述第二远程压力端口延伸到所述压力传感器的第二本地压力端口,其中,所述第二压力管路被配置为将施加在所述第二远程压力端口上的压力通过位于所述第二压力管路中的流体传递到所述第二本地压力端口;a second pressure line extending from the second remote pressure port to a second local pressure port of the pressure sensor, wherein the second pressure line is configured to be applied to the second remote pressure port the pressure of is delivered to the second local pressure port via fluid in the second pressure line; 并且其中,所述控制单元被配置为当所述远程压力端口和所述第二远程压力端口感测到的压力的差达到或者超过一选定值时,做出液体从所述液体回路中泄漏的判定。And wherein the control unit is configured to make a leak of liquid from the liquid circuit when the difference in pressure sensed by the remote pressure port and the second remote pressure port reaches or exceeds a selected value judgment. 7.根据权利要求6所述的装置,其中,所述第二选定位置被定位在相对于所述第二本地压力端口的选定高度,并且其中,位于所述液体收集器中的选定位置处的远程压力端口也相对于与其连接的所述本地压力端口位于所述选定高度。7. The apparatus of claim 6, wherein the second selected location is positioned at a selected height relative to the second local pressure port, and wherein a selected location in the liquid collector The remote pressure port at the location is also at the selected height relative to the local pressure port to which it is connected. 8.根据权利要求6至7中任一项所述的装置,其中,所述第二压力管路中的流体实质上由一种或多种气体组成。8. Apparatus according to any one of claims 6 to 7, wherein the fluid in the second pressure line consists essentially of one or more gases. 9.根据权利要求6至7中任一项所述的装置,其中,所述第二压力管路中的流体实质上由一种或多种液体组成。9. Apparatus according to any one of claims 6 to 7, wherein the fluid in the second pressure line consists essentially of one or more liquids. 10.根据权利要求1至9中任一项所述的装置,其中,所述控制单元可操作地连接到所述液体回路的一个或多个泵中的泵,并且其中,所述控制单元被配置为当所述控制单元判定所述液体回路泄漏时停止该泵的操作。10. Apparatus according to any one of claims 1 to 9, wherein the control unit is operatively connected to a pump of the one or more pumps of the liquid circuit, and wherein the control unit is controlled by configured to stop the operation of the pump when the control unit determines that the liquid circuit is leaking. 11.一种检测体外血液处理装置中的泄漏的方法,所述方法包括:11. A method of detecting leaks in an extracorporeal blood treatment device, the method comprising: 通过位于壳体上或壳体中的液体回路来泵送液体,所述液体回路包括被配置为执行体外血液处理的一个或多个泵以及管道;pumping the fluid through a fluid circuit on or in the housing, the fluid circuit comprising one or more pumps and tubing configured to perform extracorporeal blood treatment; 将从所述液体回路泄漏的液体收集在位于所述壳体下方的液体收集器中;collecting liquid leaking from the liquid circuit in a liquid collector located below the housing; 检测由收集在所述液体收集器中的液体施加在压力传感器的远程压力端口上的压力,其中,所述压力传感器位于所述壳体上或所述壳体中,并且其中,所述远程压力端口位于所述液体收集器中的选定位置;detecting pressure exerted by liquid collected in the liquid collector on a remote pressure port of a pressure sensor, wherein the pressure sensor is located on or in the housing, and wherein the remote pressure a port is located at a selected location in said liquid collector; 使用从所述远程压力端口延伸到所述压力传感器的本地压力端口的压力管路将在所述远程压力端口检测到的压力传递到所述本地压力端口,其中,所述压力管路将压力从所述远程压力端口经由位于所述压力管路中的流体传递到所述本地压力端口;以及The pressure detected at the remote pressure port is communicated to the local pressure port using a pressure line extending from the remote pressure port to the local pressure port of the pressure sensor, wherein the pressure line transfers the pressure from the remote pressure port communicates to the local pressure port via fluid in the pressure line; and 当由所述远程压力端口感测到的压力达到或超过选定的压力极限时,做出液体从所述液体回路中泄漏的判定。A determination is made that fluid is leaking from the fluid circuit when the pressure sensed by the remote pressure port reaches or exceeds a selected pressure limit. 12.一种检测体外血液处理装置中的泄漏的方法,所述方法包括:12. A method of detecting leaks in an extracorporeal blood treatment device, the method comprising: 通过位于壳体上或壳体中的液体回路来泵送液体,所述液体回路包括被配置为执行体外血液处理的一个或多个泵以及管道;pumping the fluid through a fluid circuit on or in the housing, the fluid circuit comprising one or more pumps and tubing configured to perform extracorporeal blood treatment; 将从所述液体回路泄漏的液体收集在位于所述壳体下方的液体收集器中;collecting liquid leaking from the liquid circuit in a liquid collector located below the housing; 检测由收集在所述液体收集器中的液体施加在第一远程压力端口上的压力,其中,所述第一远程压力端口位于所述液体收集器中的第一选定位置处,并且其中,所述收集器所收集的液体积累在所述第一远程压力端口上方;detecting pressure exerted by liquid collected in the liquid collector on a first remote pressure port, wherein the first remote pressure port is located at a first selected location in the liquid collector, and wherein, liquid collected by the collector accumulates above the first remote pressure port; 使用从所述第一远程压力端口延伸到位于所述壳体上或所述壳体中的压力传感器的第一本地压力端口的第一压力管路将在所述第一远程压力端口检测到的压力传递到所述第一本地压力端口,其中,所述第一压力管路将所述压力从所述第一远程压力端口经由位于所述第一压力管路中的流体传递到所述第一本地压力端口;The pressure detected at the first remote pressure port will be detected at the first remote pressure port using a first pressure line extending from the first remote pressure port to a first local pressure port of a pressure sensor located on or in the housing. pressure to the first local pressure port, wherein the first pressure line transmits the pressure from the first remote pressure port to the first pressure port via fluid in the first pressure line local pressure port; 检测作用于第二远程压力端口上的大气压力;detecting atmospheric pressure acting on the second remote pressure port; 使用从所述第二远程压力端口延伸到所述压力传感器的第二本地压力端口的第二压力管路将在所述第二远程压力端口检测到的大气压力传递到所述第二本地压力端口,其中,所述第二压力管路将压力从所述第二远程压力端口经由位于所述第二压力管路中的流体传递到所述第二本地压力端口;以及communicating atmospheric pressure detected at the second remote pressure port to the second local pressure port using a second pressure line extending from the second remote pressure port to a second local pressure port of the pressure sensor , wherein the second pressure line transfers pressure from the second remote pressure port to the second local pressure port via fluid located in the second pressure line; and 当由所述第一远程压力端口和所述第二远程压力端口感测到的压力的差达到或超过一选定值时,做出液体从所述液体回路中泄漏的判定。A determination is made that fluid is leaking from the fluid circuit when the difference in pressure sensed by the first remote pressure port and the second remote pressure port reaches or exceeds a selected value. 13.根据权利要求12所述的方法,所述第二远程压力端口被定位在相对于所述第二本地压力端口的选定高度,并且其中,所述第一远程压力端口也在相对于所述第一本地压力端口的所述选定高度。13. The method of claim 12, the second remote pressure port being positioned at a selected height relative to the second local pressure port, and wherein the first remote pressure port is also positioned relative to the second local pressure port said selected height of said first local pressure port. 14.根据权利要求11至13中任一项所述的方法,其中,压力管路中的流体实质上由一种或多种气体组成。14. A method according to any one of claims 11 to 13, wherein the fluid in the pressure line consists essentially of one or more gases. 15.根据权利要求11至14中任一项所述的方法,其中,所述方法还包括在判定液体从所述液体回路中泄漏后,停止所述液体回路中的一个或多个泵中的泵。15. The method according to any one of claims 11 to 14, wherein the method further comprises stopping pumping in one or more pumps in the liquid circuit after determining that liquid has leaked from the liquid circuit. Pump.
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