Arrangement of dialysis machine for extracorporeal blood treatment

Abstract

A dialysis machine for extracorporeal blood treatment is configured to interface with a disposable blood line having at least two different sizes available. A memory in the dialysis machine is arranged to store configuration data that associates different sizes of the blood lines with respective predetermined limits of fluid removal when the dialysis machine is operated by the controller to perform extracorporeal blood treatment. The controller is configured to perform a configuration process (400) comprising obtaining (402) size data indicative of a selected size of a blood line associated with a patient for extracorporeal blood treatment; a maximum rate of fluid removal from the blood is determined (403) by using the configuration data and based on the selected size, and the dialysis machine is configured (404) to maintain fluid removal below the maximum rate during extracorporeal blood treatment.

Description

Technical Field

[0001] The present disclosure relates generally to dialysis machines for extracorporeal blood treatment, and particularly to techniques for configuring such dialysis machines. Background Art

[0002] Extracorporeal blood therapy is a type of renal replacement therapy (RRT) that is performed to replace the normal blood filtration function of the kidneys. In extracorporeal blood therapy, blood is extracted from the patient, processed in a blood filtration unit and returned to the patient. The blood filtration unit is called a blood filter or "dialyzer" and defines a first chamber and a second chamber separated by a semipermeable membrane. As the blood is pumped through the first chamber, fluid and waste are removed from the blood by transferring through the semipermeable membrane into the second chamber. Depending on the mode, the dialysis fluid may or may not be pumped through the second chamber. Different modes of extracorporeal blood therapy include hemofiltration (HF), hemodialysis (HD), and hemodiafiltration (HDF).

[0003] Extracorporeal blood treatment is performed by a dialysis machine, which is configured to expose mechanical interfaces to various pumps, fluid connectors, sensors, etc. Before treatment, a disposable kit is installed to the dialysis machine. The disposable kit includes a dialyzer and tubing or fluid lines that define fluid pathways associated with the dialyzer. After treatment, the disposable kit is discarded.

[0004] Dialysis machines are expensive devices that are manufactured in relatively small quantities and have a long operating life. Due to the small number, there is little room for diversification, and dialysis machines are usually equipped with the ability to perform many different modes of extracorporeal blood treatment. Dialysis machines are also used independently of patient characteristics. Dialysis machines are adapted to different modes and patient characteristics by using different disposable kits and by the caregiver calculating and inputting the operating parameters of the dialysis machine to meet the needs of a specific patient.

[0005] For example, pediatric dialysis can be performed by using a universal dialysis machine. Since the total blood volume of children is much smaller than that of adults, the disposable kit usually has a fluid channel with a smaller inner diameter to accommodate a smaller amount of blood. However, when a universal dialysis machine is used for pediatric dialysis, there is a risk that the caregiver configures the dialysis machine by inputting operating parameters that are acceptable for adult patients but inappropriate or even harmful for children. A dialysis machine suitable for extracorporeal blood treatment for adults may not be able to detect this inappropriate configuration. Summary of the invention

[0006] One object is to at least partially overcome one or more limitations of the prior art.

[0007] One object is to provide a technique which reduces the risk of a dialysis machine being misconfigured when used on patients with a small total blood volume.

[0008] Another object is to provide a technique that can be simply retrofitted to existing dialysis machines.

[0009] One or more of these objects, as well as other objects that may emerge from the following description, are achieved at least in part by a dialysis machine, a computer-implemented method and a computer-readable medium, embodiments of which are defined by the dependent claims.

[0010] A first aspect is a dialysis machine comprising: a first pumping device configured to interface with a disposable blood line, the disposable blood line being in fluid communication with a first compartment of the dialyzer, the blood line being available in at least two different sizes. The dialysis machine also comprises a second pumping device configured to interface with a line set, the line set being in fluid communication with a second compartment of the dialyzer, the second compartment being separated from the first compartment by a semipermeable membrane. The second pumping device is operable to control fluid removal from the blood in the first compartment through the semipermeable membrane. The dialysis machine also comprises: a user interface for interacting with a user of the dialysis machine; a memory for storing configuration data associating different sizes of the blood line with corresponding predetermined limits of the fluid removal; and a controller connected to the memory and the user interface and configured to operate the first and second pumping devices to perform extracorporeal blood treatment. The controller is also configured to, during the configuration process: obtain dimensional data indicating a selected dimension of a blood line associated with a patient for extracorporeal blood treatment; determine a maximum rate of removal of the fluid from the blood by using the configuration data and based on the selected dimension; and configure the dialysis machine to maintain fluid removal below the maximum rate during the extracorporeal blood treatment.

[0011] In some embodiments, the controller is configured to obtain the dimensional data through a user interface.

[0012] In some embodiments, the configuration data includes at least one predetermined limit value specific to pediatric dialysis and at least one predetermined limit value specific to non-pediatric dialysis.

[0013] In some embodiments, the controller is further configured to obtain a current weight of the patient, wherein the controller is configured to determine the maximum rate based on the current weight of the patient and a predetermined limit associated with the selected size.

[0014] In some embodiments, the predetermined limit defines a maximum rate of fluid removal per unit body weight.

[0015] In some embodiments, the controller is configured to obtain the current weight by prompting the user to input the current weight through a user interface.

[0016] In some embodiments, the controller is configured to obtain the current weight only if the selected size falls within a certain size range.

[0017] In some embodiments, a particular size range is indicative of blood lines used for pediatric dialysis.

[0018] In some embodiments, the controller includes: a first module configured to perform a configuration process; and a second module configured to estimate the processing efficiency of extracorporeal blood treatment based on conductivity data from a sensor device in a dialysis machine, the second module being operable to allow input of a current weight through a user interface, and the first module being configured to obtain the current weight by using the second module.

[0019] In some embodiments, the configuration data further associates different sizes with corresponding weight ranges, and the controller is further configured to evaluate the current weight relative to the weight range associated with the selected size of the blood line and present a weight alert on the user interface if the current weight deviates from the weight range.

[0020] In some embodiments, the controller is further configured to present the maximum rate on the user interface.

[0021] In some embodiments, the controller is further configured to determine a selected rate of fluid removal for extracorporeal blood treatment based on input data obtained through the user interface, evaluate the selected rate relative to a maximum rate, and present a rate alert on the user interface if the selected rate exceeds the maximum rate.

[0022] In some embodiments, the first pumping device includes a peristaltic pump, and the different sizes correspond to different inner diameters of a portion of the blood tubing configured to engage one or more rollers of the peristaltic pump.

[0023] A second aspect is a computer-implemented method for configuring a dialysis machine to perform extracorporeal blood treatment. The dialysis machine includes: a user interface; a first pumping device configured to interface with a disposable blood line, the disposable blood line being in fluid communication with a first compartment of the dialyzer, the blood line being available in at least two different sizes; and a second pumping device configured to interface with a line set, the line set being in fluid communication with a second compartment of the dialyzer, the second compartment being separated from the first compartment by a semipermeable membrane, and the second pumping device being operable to control fluid removal from the blood in the first compartment through the semipermeable membrane during the extracorporeal blood treatment. The computer-implemented method includes: obtaining size data indicating a selected size of a blood line associated with a patient for extracorporeal blood treatment; retrieving configuration data from a memory, the configuration data associating different sizes of the blood line with corresponding predetermined limits of the fluid removal; determining a maximum rate of fluid removal from the blood by using the configuration data and based on the selected size; and configuring the dialysis machine to keep fluid removal below the maximum rate during the extracorporeal blood treatment.

[0024] As found herein, any embodiment of the first aspect may be adapted and implemented as an embodiment of the second aspect.

[0025] A third aspect is a computer readable medium comprising computer instructions which, when executed by a processor, cause the processor to perform the method of the second aspect or any embodiment thereof.

[0026] The aforementioned aspects provide a technique for supporting users when configuring a dialysis machine for extracorporeal blood treatment to mitigate the risk of the dialysis machine being misconfigured when used for patients with a smaller total blood volume (e.g., children). The configuration process is based on the following recognition: the maximum rate of fluid removal can be determined based on the size of the blood line to be used in the treatment, because the size needs to be known so that the dialysis machine operates the first pumping device to provide the correct blood flow rate through the dialyzer. Therefore, through the configuration process, the dialysis machine is inherently configured to keep the fluid removal below the maximum rate of the total blood volume suitable for the patient. In addition, the provision of configuration data enables, for example, the predetermined limit value to be simply updated according to the needs of a specific clinic, ward, or dialysis machine. Whenever a blood line of a new size is available for installation in the first pumping device, the configuration data can also be simply updated. In addition, the configuration process is easy to implement on a pre-existing dialysis machine, for example, by updating the control program stored in the controller and by providing appropriate configuration data.

[0027] Other objects, aspects, embodiments and technical effects as well as features and advantages will appear from the following detailed description, from the appended claims as well as from the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Figure 1Ais a front view of an example dialysis machine for extracorporeal blood treatment, Figure 1B When configured and operated for extracorporeal blood treatment Figure 1A A diagram of a dialysis machine in FIG. Figure 1C is used for Figure 1A Block diagram of an example controller for a dialysis machine in FIG.

[0029] Figure 2A yes Figure 1A A front view of a blood pump in a dialysis machine, and Figure 2B and Figure 2C Is used to install Figure 2A Side view of the different sized pump segments in a peristaltic pump.

[0030] Figure 3A is a block diagram of an example dialysis machine, and Figure 3B Configuration data for configuring a dialysis machine is depicted.

[0031] Figure 4A and Figure 4B is a flow chart of an example computer-implemented method of configuring a dialysis machine.

[0032] FIG. 5A to FIG. 5E Shown by Figure 4A and Figure 4B Example message displayed in the user interface by the method in

[0033] Figure 6 is a block diagram of a controller including a separate software module for monitoring treatment efficiency. DETAILED DESCRIPTION

[0034] Embodiments will now be described more fully hereinafter with reference to the accompanying drawings, in which some but not all embodiments are shown. Indeed, the subject matter of the present disclosure may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure may satisfy applicable legal requirements.

[0035] Moreover, it should be understood that, where possible, any advantages, features, functions, devices and / or operational aspects of any embodiment described and / or contemplated herein may be included in any other embodiment described and / or contemplated herein, and / or vice versa. In addition, where possible, unless otherwise expressly stated, any term expressed in the singular herein is intended to also include the plural form and / or vice versa. As used herein, "at least one" shall mean "one or more", and these phrases are intended to be interchangeable. Therefore, the terms "one" and / or "an" shall mean "at least one" or "one or more", even if the phrases "one or more" or "at least one" are also used herein. As used herein, unless the context requires otherwise due to clear language or necessary meaning, the word "comprise" or variations such as "comprises" or "comprising" are used in an inclusive sense, that is, specifying the presence of the features but not excluding the presence or addition of other features in various embodiments.

[0036] As used herein, the terms "multiple," "plural," and "plurality" are intended to imply the presence of two or more elements. The term "and / or" includes any and all combinations of one or more of the associated listed elements.

[0037] In addition, it will be understood that although the terms first, second, etc. can be used to describe various elements in this article, these elements should not be limited by these terms. These terms are only used to distinguish one element from another element. For example, without departing from the scope of the present disclosure, the first element can be referred to as the second element, and similarly, the second element can be referred to as the first element.

[0038] For the sake of brevity and / or clarity, well-known functions or constructions may not be described in detail. Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the present disclosure belongs.

[0039] Like reference numerals refer to like elements throughout.

[0040] Figure 1A1 is a front view of an example dialysis machine 10, which will be used to describe various embodiments. The dialysis machine 10 (also referred to as a "monitor" in the art) is configured to be combined with a set of disposable components ("disposable kit") to define a dialysis system that is operable to perform extracorporeal blood treatment. The dialysis machine 10 includes a housing or chassis 11, which, according to conventional practice, encloses various internal components (represented by dotted lines) and defines a mechanical interface for engaging with a disposable kit. In the example shown, the housing 11 is mounted on a bracket 12 on wheels and includes a control device 13, a user interface (UI) device 14, a blood pump 15, a fluid supply device 16, a treatment fluid pump 17a, 17b and fluid ports 18a, 18b. The control device 13 is configured to control the operation of the dialysis machine 10. The UI device 14 is electrically connected to the control device 13. The term "UI device" is intended to include any and all devices capable of performing guided human-computer interaction (including the presentation of information and the reception of input). Thus, UI device 14 may include a combination of presentation device and data input hardware. The presentation device may include one or more of a display, a speaker, a projector, a light, etc. The data input hardware may include one or more of a keyboard, a keypad, a computer mouse, control buttons, a touch panel, a microphone and voice control functionality, a camera and gesture control functionality, etc. In one embodiment, UI device 14 is or includes a touch-sensitive display, which is also referred to as a touch screen.

[0041] The blood pump 15 is configured to engage with tubing or fluid lines in the disposable kit and is operable to drive blood through the tubing. In the example shown, the blood pump 15 is a peristaltic pump. Although Figure 1A A single blood pump 15 is shown in FIG, but it is conceivable that the dialysis machine 10 includes multiple blood pumps. Therefore, typically, the dialysis machine 10 includes a first pumping device that is operable to pump blood through one or more fluid lines of the disposable kit. A fluid supply device 16 is configured to provide a treatment fluid for extracorporeal blood treatment. The fluid supply device 16 can be configured to provide a treatment fluid from a pre-filled bag mounted on the dialysis machine 10, or to generate a treatment fluid as required, for example, by mixing one or more concentrates with purified water. A treatment fluid pump ("supply pump") 17a is operable to supply fresh treatment fluid to a fluid port 18a, and a treatment fluid pump ("effluent pump") 17b is operable to receive a used treatment fluid at a fluid port 18a. It can be seen that pumps 17a, 17b form (a part of) a second pumping device of the dialysis machine 10. As used herein, a "used" treatment fluid refers to a treatment fluid that has been used for extracorporeal blood treatment and contains fluids and solutes extracted from blood.

[0042] Figure 1B1 is a side view of the dialysis machine 10 when configured for hemodialysis (HD). Internal components are shown on the left side of the housing 11, and disposable components of the mechanical interface attached to the housing 11 are shown on the right side. The blood pump 15 is arranged to protrude from the housing 11 to expose a mounting portion for engaging with the blood line 6 (below). The supply pump 17a is arranged in an output fluid path extending from the fluid supply device 16 to the fluid port 18a, and the effluent pump 17b is arranged in an input fluid path extending from the fluid port 18b to the fluid supply device 16. The fluid supply device 16 can be configured to regenerate the used treatment fluid into fresh treatment fluid, or to direct the used treatment fluid to a drain (not shown) for disposal.

[0043] exist Figure 1B In the example shown, respective sensors 19a, 19b are arranged on the output fluid path and the input fluid path to measure a property of the treatment fluid passing therethrough. The measured property is a concentration-related parameter, such as the conductivity or the concentration of one or more substances. The output signals of the sensors 19a, 19b generated during a specific test sequence performed by the dialysis machine 10 can be processed by the control device 13 to determine the efficiency of the blood treatment being performed, as is known in the art. Reference will be made below to Figure 6 The use of sensors 19a, 19b is further described.

[0044] Disposable parts (such as Figure 1B The disposable component 10 (shown on the right side of the housing 11) includes a hemofilter 2, commonly referred to as a "dialyzer". The dialyzer 2 includes a semipermeable membrane 2', which divides the dialyzer 2 into a first compartment 2a for blood and a second compartment 2b for treatment fluid. The disposable component also includes a set of fluid lines ("line set"). The line set includes a supply line 3 for fresh treatment fluid and a discharge line 4 for used treatment fluid. The supply line 3 includes a connector 5a for releasably connecting to port 18a, and the discharge line 4 includes a connector 5b for releasably connecting to port 18b. By connecting to ports 18a, 18b, the fluid lines 3, 4 are "interfaced" with fluid pumps 17a, 17b. The fluid lines 3, 4 are releasably or permanently connected to the dialyzer 2, in fluid communication with compartment 2b. The line set also includes a blood inflow line 6 and a blood outflow line 7, which are releasably or permanently connected to the dialyzer 2, and are in fluid communication with the compartment 2a. Access devices 8a, 8b are arranged at the distal ends of the fluid lines 6, 7, and are configured to be connected to a block 9, which can represent a patient or a blood reservoir. When connected to a patient, the corresponding access devices 8a, 8b can be a needle or a catheter, as known in the art. As shown, the blood inflow line 6 is arranged to engage with a blood pump 15. Instead of a collection of tubes as shown, the line set can be implemented as an integrated box, as known in the art.

[0045] In a variant not shown, the fluid pumps 17a, 17b are instead peristaltic pumps arranged to protrude from the housing 11 to engage with the supply line 3 and the drain line, respectively. In such a variant, the supply line 3 may extend from a fluid supply 16 (e.g. a pre-filled bag of treatment fluid) to the dialyzer 2, and the drain line 4 may extend from the dialyzer 2 to the drain.

[0046] Figure 1C 1 is a schematic diagram of a control device ("controller") 13 according to an embodiment. The control device 13 is configured to receive measurement signals collectively represented by Sj and generate control signals collectively represented by Ci. The control device 13 can be configured to generate control signals Ci according to a control program (software) and based on the measurement signals Sj. The control signal Ci is provided to various functional components of the dialysis machine 10, including but not limited to a blood pump 15 and fluid pumps 17a, 17b. The measurement signal Sj is generated by various sensors (not shown) in the dialysis machine 10 and / or in the disposable kit, such as pressure sensors, flow meters, temperature sensors, blood leakage sensors, air detectors, etc. The measurement signal Sj also includes signals from sensors 19a, 19b (if present). The control device 13 includes a circuit including one or more processors 131 and a computer memory 132. The control program is stored in the memory 132 and executed by the processor 131. The control program may be provided to the control device 13 on a computer readable medium, which may be a tangible (non-transitory) product (e.g., magnetic medium, optical disk, read-only memory, flash memory, etc.) or a propagation signal. In the example shown, the control device 13 includes: a first signal interface 133a for providing control signals Ci and receiving measurement signals Sj; and a second signal interface 133b for connecting to the UI device 14. The first interface 133a and the second interface 133b may be combined into a single interface.

[0047] When the disposable set has been connected to the dialysis machine 10, as shown Figure 1B As shown, the control device 13 is operable to control the dialysis machine 10 to perform extracorporeal blood treatment. During such treatment, the blood pump 15 is operated to pump blood from the patient 9, through the compartment 2a, and back to the patient, and the fluid pumps 17a, 17b are operated to pump the treatment fluid through the compartment 2b, as shown by the arrows. Thereby, fluid and solutes are exchanged between the blood and the treatment fluid across the semipermeable membrane 2'. The extraction of fluid from the blood to the treatment fluid is controlled by the fluid pumps 17a, 17b and is referred to as ultrafiltration (UF). The exchange of solutes is primarily driven by diffusion. In HD, the treatment fluid pumped through the dialyzer 2 is typically denoted "dialysis fluid".

[0048] Figures 1A to 1Cis simplified and is intended only to provide context for the following description. Thus, the dialysis machine 10 and disposable kits may include other components not shown or discussed herein, including additional fluid pumps, to enable other modes of extracorporeal blood treatment. Figure 1A and Figure 1B The configuration of the dialyzer 10 and disposable kit in has been given for hemodialysis (HD), but the present disclosure is equally applicable to other modes, such as hemofiltration (HF) and hemodiafiltration (HDF). In HF, the treatment fluid is not supplied to the dialyzer 2, and the UF is controlled by the effluent pump 17b, which is operated to pump fluid through the membrane 2' as usual. The extracted fluid is partially or completely replaced by the treatment fluid ("replacement fluid") injected into the blood line 6 or 7. HDF combines HD and HF, and therefore involves pumping fresh dialysis fluid through the compartment 2b of the dialyzer 2 according to HD, and partially or completely replacing the extracted fluid with the replacement fluid according to HF. It should be recognized that the same dialyzer 10 can be operated to perform different modes by installing a dedicated disposable kit in the dialyzer 10 and entering dedicated control settings for the control program.

[0049] Figure 2A 1 is a front view of an example pump head of a blood pump 15 on a dialysis machine 10. The blood pump 15 is a rotary peristaltic pump, and the pump head includes a fixed frame 151 and a concentrically arranged rotor, the fixed frame 151 defining a curved support surface for a line segment 6' of a blood line 6. The line segment 6' is also referred to as a "pump segment" in the art. The pump segment 6' is mounted to extend parallel to the curved support surface. The pump segment 6' is a flexible tubing portion. In some embodiments, the pump segment 6' may be structurally different from other portions of the blood line 6. For example, the pump segment 6' may be reinforced and / or made of a thicker and / or stronger material to maintain the engagement force from the pump 15 over time. In the example shown, the rotor includes two rollers 152, 154, which are rotatably arranged on respective arms 153, 155, which are fixedly arranged on a central hub 156. The rollers 152, 154 are also referred to as boots, wipers, or blades. The drive shaft 157 is fixedly attached to the hub 156 and is connected for rotation by an electric motor (not shown). When the rotor turns, a portion of the pump segment 6' is compressed by the corresponding rollers 152, 154 and is thereby clamped closed ("occluded") so that the fluid is driven along the pump segment 6'. The rotor of the pump 15 may carry more than two rollers 152, 154.

[0050] As can be appreciated from the foregoing, the dialyzer 10 comprises: a first pumping device comprising a blood pump 15; and a second pumping device comprising at least an effluent pump 17b. The first pumping device is configured to interface with a disposable blood line 6, which is in fluid communication with the compartment 2a of the dialyzer 2. The second pumping device is configured to interface with a line set 3, 4, which is in fluid communication with the compartment 2b of the dialyzer 10 and is operable to control the removal of fluid from the blood in the first compartment through the membrane 2'.

[0051] As described in the background section, when the disposable kit is installed on the dialysis machine 10, the caregiver can have pump segments 6' of different sizes to choose from. The pump segment 6' can be formed integrally with the blood line 6, or a connection portion for attachment to the blood line 6 can be provided separately. In this case, the size of the pump segment 6' refers to the amount of blood pumped per unit time by the blood pump 15 when the blood pump 15 engages the pump segment 6'. Typically, the size of the pump segment 6' is given by its inner diameter. Figure 2B to Figure 2C Pump segments 6' are shown with different inner diameters D1, D2. In a non-limiting example, the pump segments may have inner diameters of 8 mm, 6.4 mm, and 4 mm. The remainder of the blood line 6 may or may not have the same inner diameter as the pump segment 6'. As used herein, any reference to the size of the blood line 6 refers to the size of its pump segment 6'. The size of the pump segment is hereinafter abbreviated as PSS.

[0052] Figure 3A For example Figure 1A Block diagram of an example dialysis machine of the type shown. The control device 13 is configured to control the operation of the dialysis machine by providing a control signal to a first pumping device 15, thereby operating the blood pump, and by providing a control signal to a second pumping device 17, thereby operating at least an effluent pump 17b and possibly a supply pump 17a (depending on the mode). The control device 13 is also connected to a UI device 14, through which the control device 13 is operable to receive control settings and other input data from a user of the dialysis machine 10 and provide instructions to the user. The control settings define the operation of the dialysis machine during a treatment course. Examples of control settings include the total amount of fluid removed for a treatment course (total UF), the duration of a treatment course (treatment time, TT), the flow rate of blood entering the dialyzer (BFR), the flow rate of treatment fluid entering the dialyzer (DFR), etc.

[0053] The control device 13 is also connected to a memory 13', which may be a computer memory 132 ( Figure 1C) or part of an external memory unit. The memory 13' is operable to store configuration data CD, which associates different pump segment sizes (PSS) with corresponding predetermined limit values ​​of fluid removal achieved by the dialysis machine 10 during ongoing treatment. The use and structure of the configuration data will be further described below. As shown by the dotted line, the control device 13 can also be connected to a reader 20, which is operable to detect the identification code of the pump segment before, during or after the pump segment is installed on the dialysis machine 10. The identification code can be provided on the external packaging of the pump segment or on the pump segment itself. For example, the reader 20 can be an optical scanner or an RFID reader, and the identification code can be provided in a corresponding format.

[0054] The technical scheme described herein is intended to mitigate the risk of the dialysis machine 10 being misconfigured or operated when used for a "smaller patient", which has a relatively small total blood volume compared to a "normal patient". As used herein, a smaller patient has a weight of 30 kg or less, and a normal patient has a weight of more than 30 kg. In the context of the present disclosure, dialysis for smaller patients is referred to as "pediatric dialysis", even if the smaller patient is not an infant, child or adolescent. In pediatric dialysis, the fluid removal rate (ultrafiltration rate, UFR) should be reduced compared to that of a normal patient. Otherwise, there is a risk of symptomatic hypotension in the patient, which is characterized by a drop in blood pressure, with symptoms in the form of cramps, nausea, vomiting and sometimes fainting. Such an event is not only laborious for the patient, but also requires considerable attention from the staff supervising the treatment. Therefore, when configuring the dialysis machine for pediatric dialysis, the caregiver must enter the appropriate control settings via the UI device 14. The dialysis machine is typically configured to perform a safety check of the control settings before starting a treatment course to ensure that the control settings are within safety limits and to warn the user if they are not within safety limits. However, if the dialysis machine 10 is used for the treatment of both normal and smaller patients, the safety margins are appropriate for normal patients and the safety check may not detect if the UFR is set too high for smaller patients.This problem may also apply to other control settings.

[0055] This technical solution takes advantage of the practice of installing a smaller pump segment 6' in the blood pump 15 when pediatric dialysis is to be performed, thereby reducing the blood flow rate per unit time generated by the blood pump 15. Typically, the caregiver inputs the size of the installed pump segment 6' into the dialysis machine 10 via the UI device 14, thereby allowing the dialysis machine 10 to operate the blood pump 15 to achieve the blood flow rate (BFR) according to the control settings.

[0056] There is often a need to support users who configure dialysis machines for pediatric dialysis. In the context of the present disclosure, a "user" may be a caregiver, a patient, or any other individual who configures a dialysis machine for treatment.

[0057] Figure 4A 4 is a flow chart of an example process 400 for configuring a dialysis machine for an extracorporeal blood treatment session. Figure 3A Describe the configuration process 400. In step 401, the configuration data (CD) is stored in the memory 13'. Figure 4A As shown, CD includes an association A1 between the blood line size (PSS) and the fluid removal limit (MUFR). The fluid removal limit represents a maximum value and can be given as an absolute UFR value (MUFRa) or as a weight-based UFR value (MUFRw). Thus, it can be seen that MUFRRa defines the maximum UFR, and it can be seen that MUFRw defines the maximum UFR per unit of patient weight. Given MUFRw, MUFRRa can be determined as the product of MUFRw and the patient's weight. Step 401 can be performed at any time prior to a treatment session. For example, configuration data can be predefined for all dialysis machines in a clinic and entered into memory 13' as default settings for the dialysis machine 10. Figure 3B An example of configuration data CD is shown in FIG. Here, PSS is represented by inner diameters D1 to Dn (see Figure 2B to Figure 2C ), and the MUFR is given by the corresponding limit values ​​LV1 to LVn. In some embodiments, D1 to Dn represent at least one pump segment suitable for pediatric dialysis and at least one pump segment suitable for use with normal patients.

[0058] In step 402, the control device 13 obtains dimensional data indicative of a selected PSS for an upcoming treatment session. The selected PSS represents a pump segment 6' that is or will be installed on the blood pump 15 for the upcoming treatment session. The dimensional data may be given as an inner diameter, a serial number, or any other unique identifier. In some embodiments, the dimensional data is input by a user via the UI device 14. In other embodiments, the dimensional data is obtained from the reader 20 ( Figure 3A ) output signal to infer the size data. The reader 20 can be arranged in association with the blood pump 15 so as to be mounted on the pump head (see Figure 2A ) automatically reads the identification code of the pump section when it is installed. Alternatively, the control device 13 can prompt the user to bring the identification code into the range of the reader 20 before or after installation.

[0059] In step 403, the control means 13 determines the maximum UF rate (MUFRa) by using the configuration data and based on the selected PSS given by the dimension data. Thus, step 403 may comprise retrieving CD from the memory 13' and using the association A1 to determine MUFRa based on the selected PSS directly or by using MUFRw.

[0060] In step 404, the control device 13 configures the dialysis machine 10 to maintain the UFR below MUFRRa throughout the treatment course. As described above, the user can input a control setting for the UFR ("UFR setting") via the UI device 14 prior to the treatment course. The UFR setting (also referred to herein as "selected UFR") can be a fixed value or a time curve of the UFR. In some embodiments, step 404 includes evaluating the UFR setting to ensure that it does not exceed MUFRRa prior to starting the treatment course, and requesting the user to change the UFR setting if deemed necessary.

[0061] The process 400 will provide user support to ensure that the dialysis machine 10 is not configured in a manner that endangers the health of the patient with respect to UFR, regardless of the patient's size / weight / age. The process 400 enables the dialysis machine 10 to perform an automatic check of the UFR settings whenever a pediatric pump segment 6' of known size is installed in the dialysis machine 10. Furthermore, the provision of predefined configuration data enables simple updating of the predefined limit values ​​LV1 to LVn, for example, depending on the needs of a particular clinic, ward or dialysis machine. Furthermore, the configuration data can be simply updated whenever a new PSS is available for installation on the dialysis machine. The process 400 is easy to implement on pre-existing dialysis machines by updating the control program stored in the control device 13, and optionally by installing a reader 20. The process 400 is also applicable to any available extracorporeal blood treatment mode.

[0062] It should be appreciated that if the MUFRw value is included in the configuration data, the patient's weight needs to be known or estimated so that the corresponding MUFRRa value can be calculated. In some embodiments, in order to simplify deployment, the configuration data can therefore be defined as including only MUFRRa values ​​associated with PSS values. However, by including the MUFRw value in the configuration data, a greater diversity of MUFRRa values ​​is achieved. The provision of MUFRw values ​​may be particularly desirable for smaller patients, where the sensitivity to UFR may vary significantly with the patient's total blood volume. In some embodiments, the configuration data associates a pump segment suitable for smaller patients ("pediatric pump segment") with a corresponding MUFRw value within the range of 8-10 ml / kg / h. The pediatric pump segment may have an inner diameter of less than 8 mm, such as 6.4 mm or 4 mm. It is conceivable that pediatric pump segments of different sizes are associated with the same MUFRw value. On the other hand, a pump segment suitable for conventional patients ("conventional pump segment") may be associated with, for example, a MUFRRa value within the range of 1000-2000 ml / h or a MUFRw value within the range of 12-14 ml / kg / h. Conventional pump sections may have an inner diameter of 8 mm or more.

[0063] Figure 4BAnother example of a configuration process 400 is shown. In this example, the configuration data comprises a MUFRw value, which is converted to a MUFRRa value by using the patient's current weight. Furthermore, the configuration process 400 performs an additional check that the selected PSS is appropriate for the patient's current weight. To enable the additional check, the configuration data comprises, in addition to the association A1, another association A2 between the blood line size (PSS) and the allowed weight range (WR). Back Figure 3B The configuration data in represents the association A2 by providing a weight range value ΔW1 to ΔWn.

[0064] Similar to Figure 4A , Figure 4B The process 400 in includes a step 401 of storing configuration data in the memory 13', and a step 402 of obtaining size data indicative of a selected PSS. The process 400 includes intermediate steps 410-415 between step 402 and step 403. In step 410, the control device 13 checks whether the selected PSS is associated with pediatric dialysis, for example by comparing the selected PSS with a predetermined size range for pediatric dialysis. If not, step 410 proceeds to step 403. Otherwise, step 410 proceeds to step 411, where the user is prompted to enter the patient's current weight via the UI device 14. Figure 5A An example of a dialog box 501 that may be presented on the screen of the UI device 14 in step 411 is shown. If the user activates the cancel button (x) in the dialog box 501, step 411 may return to step 402. If the user activates the confirm button (√), step 411 may present a Figure 5B The interface 502 allows the user to manually input the patient's current weight and then activate the confirmation button (√) to submit the current weight to the control device 13. The user can postpone the input of the current weight by activating the cancel button (x). If the weight input is postponed, the control device 13 can be configured to present a persistent message on the UI device 14 notifying the user that the current weight needs to be input, such as Figure 5C Message 503 in. As shown, message 503 directs the user to a dedicated menu ("fluid menu") for inputting current weight. Figure 5D An example of such a menu 504 is shown, which is arranged to enable a user to enter control settings and view various characteristics of a dialysis machine or treatment. Figure 5D , the user has activated the tab "UF," which gives the user the ability to input UF-related control settings, including total UF ("UF Target"), treatment time, and current weight ("Patient Weight").

[0065] As used herein, "weight" is any parameter related to the total body water in a patient. For example, weight can be given as body mass, body volume, height, body water volume, body water mass, distribution volume, etc.

[0066] In a variation of step 411 , the control device 13 obtains the patient's current weight from an electronic medical record (EMR) or from a dedicated measuring device connected to the control device 13 , such as a weighing scale.

[0067] In step 412, the control device 13 determines the permissible weight range for the selected PSS by using the configuration data. Figure 3B In the example of , step 412 includes accessing the configuration data CD and determining the WR value associated with the selected PSS. In step 413, the current weight is evaluated relative to the weight range given by the WR value. If the current weight falls within the weight range, step 413 proceeds to step 403. Otherwise, step 413 proceeds to step 414, where a weight alarm (alarm 1) is presented on the UI device 14. The weight alarm can indicate the allowed weight range and prompt the user to change the selected PSS. Therefore, step 413 solves the risk of the user installing an inappropriately sized pediatric pump segment in the blood pump 15.

[0068] As indicated, step 415 may allow a user to override a request to change the selected PSS. Unless an override command is entered, step 415 proceeds to step 402. An override command causes step 415 to proceed to step 403.

[0069] Similar to Figure 4A , step 403 determines a maximum UF rate (MUFRa) by using the configuration data and based on the selected PSS given by the dimensional data. However, in the example shown, step 403 is performed differently depending on the result of step 410. If the selected PSS is associated with non-pediatric dialysis (conventional patient), step 403B is performed. Step 403B does not take into account the patient's current weight. Instead, the MUFRa is given by the limit values ​​(LV1-LVn) associated with the selected PSS (D1-Dn) in the configuration data (see Figure 3B ). On the other hand, if the selected PSS is associated with pediatric dialysis, step 403A is performed. Step 403A takes into account the patient's current weight by obtaining the MUFRw for the selected PSS and multiplying the MUFRw by the current weight to generate MUFRa. It should be appreciated that step 403A may involve operations to convert MUFRw and / or current weight so that they are given in the same weight units, such as body mass, body water volume, etc.

[0070] and Figure 4AAs in, step 404 configures the dialysis machine for the upcoming treatment course. In the example shown, step 404 includes sub-steps 420-425. In step 420, the control device 13 presents MUFRa to the user on the UI device 14. In step 421, the control device 13 obtains the UFR setting ("selected UFR") for the upcoming treatment course, for example, via the UI device 14. It should be recognized that the presentation in step 420 can help the user determine the UFR setting. In step 421, the UFR setting can be directly input by the user, or calculated based on other control settings input by the user. For example, according to conventional practice, the user can enter the total UF and the processing time, so that the control device 13 calculates the UFR setting by dividing the total UF by the processing time. In step 422, the UFR setting is evaluated relative to MUFRa. If the UFR setting is lower than MUFRa, step 422 proceeds to step 423, where the control device 13 starts the treatment course according to the UFR setting and other control settings, which can be input by the user or determined in other ways. If the UFR setting exceeds MUFRa, step 422 proceeds to step 424, where an alarm (alarm 2) is presented on the UI device 14. The alarm may indicate that the UFR setting violates the dialysis regimen and prompt the user to change the UFR setting. As shown, step 425 may allow the user to override the request to change the UFR setting. Unless an override command is entered, step 425 proceeds to step 421. The override command causes step 425 to proceed to step 423. Figure 5E An example of a dialog box 505 is shown that may be presented on the screen of the UI device 14 in step 424. If the user activates the confirmation button (√) in the dialog box 505, step 424 proceeds to step 421. If the user activates the cancel button (x), overwriting is performed.

[0071] exist Figure 4B In one embodiment, the user first identifies the selected PSS to the control device 13 (step 402), and optionally identifies the current weight (step 411), and then enters the UFR setting for the upcoming treatment session (421), whereupon the control device 13 is operated to verify the UFR setting (step 422) before initiating the treatment session (step 423). In one variation, the user first enters the UFR setting (step 421), and then identifies the selected PSS to the control device 13 (step 402), and optionally identifies the current weight (step 411), whereupon the control device 13 is operated to verify the UFR setting (step 422). In this variation, step 420 would be omitted.

[0072] exist Figure 4BIn another variation of , step 410 is omitted and intermediate steps 411-415 are performed for any selected PS. In addition, step 403B may be performed to take into account the current weight corresponding to step 403A.

[0073] Figure 6 is a block diagram of a control device 13 comprising two separate program modules 13a, 13b, each of which contains programs configured to be executed by a processor in the control device 13 (see Figure 1C The program module 13a (MOD1) is configured to generate program codes (software) for the functional components (such as the first pumping device 15 and the second pumping device 17) in the dialysis machine 10. Figure 3A )) to control the dialysis machine to perform a treatment course according to conventional practice. MOD1 is also configured to perform a configuration process 400. Program module 13b (MOD2) is configured to perform a configuration process 400 based on the control signal (Ci) from the conductivity sensors 19a, 19b ( Figure 1B ) and also evaluates the treatment efficiency (EFF) of the treatment course based on the patient's weight before the treatment course. Monitoring system or from Fresenius Monitoring system to configure. As shown, MOD2 is configured to present a query QY1 on the UI device 14, prompting the user to enter the current weight, which is included in the input data IN1 for MOD2. When executing the configuration process 400, MOD1 presents one or more queries QY2 on the UI device 14, prompting the user to enter size data (step 402) and UFR settings (step 421), which form the input data IN2 for MOD2. In addition, as shown, MOD1 is configured to obtain the current weight (CW) by using MOD2. For example, if MOD2 has received CW and stored CW in a memory, MOD1 can read CW from the memory. Alternatively, MOD1 can prompt the user via the UI device 14 to call a dedicated dialog box available through MOD2 and enter the current weight via the dedicated dialog box. In another alternative, MOD1 can provide instructions to MOD2 to call a dedicated dialog box, provided that MOD2 provides an appropriate interface (API) for receiving external instructions. By configuring MOD1 to obtain CW via MOD2, MOD1 is simplified and can be prepared with minimal modification of conventional program code for controlling a dialysis machine.

[0074] While the disclosed subject matter has been described in connection with what are presently considered to be the most practical embodiments, it is to be understood that the disclosed subject matter is not limited to the disclosed embodiments, but on the contrary is intended to cover various modifications and equivalent arrangements included within the spirit and scope of the appended claims.

[0075] Further, while operations are depicted in the drawings in a particular order, this should not be understood as requiring that such operations be performed in the particular order shown or in sequential order, or that all illustrated operations be performed, to achieve desirable results.

Claims

1. A dialysis machine, comprising: a first pumping device (15) configured to interface with a disposable blood line (6) in fluid communication with the first compartment (2a) of the dialyzer (2), the blood line (6) being available in at least two different sizes, a second pumping device (17a, 17b) configured to interface with a line set (3, 4) in fluid communication with a second compartment (2b) of the dialyzer (2), the second compartment (2b) being separated from the first compartment (2a) by a semipermeable membrane (2'), the second pumping device (17) being operable to control fluid removal from blood in the first compartment (2a) through the semipermeable membrane (2'), a user interface (14) for interacting with a user of the dialysis machine, a memory (13') for storing configuration data (CD) associating different sizes of the blood line (6) with corresponding predetermined limit values ​​for the fluid removal, and a controller (13) connected to the memory (13') and the user interface (14) and configured to operate the first and second pumping devices (15, 17) to perform extracorporeal blood treatment, The controller (14) is further configured to, during the configuration process (400): obtaining dimensional data indicating a selected dimension of the blood line (6) for the extracorporeal blood treatment associated with the patient, determining a maximum rate of removal of said fluid from the blood based on said selected size by using said configuration data (CD), and The dialysis machine is configured to maintain the fluid removal below the maximum rate during the extracorporeal blood treatment.

2. The dialysis machine according to claim 1, wherein: The controller (13) is configured to obtain the size data through the user interface (14).

3. The dialysis system according to claim 1 or 2, wherein: The configuration data (CD) comprises at least one predetermined limit value specific to pediatric dialysis and at least one predetermined limit value specific to non-pediatric dialysis.

4. The dialysis machine according to any one of the preceding claims, wherein: The controller (13) is further configured to obtain (411) a current weight of the patient, wherein the controller (13) is configured to determine the maximum rate based on the current weight of the patient and the predetermined limit value associated with the selected size.

5. The dialysis machine according to claim 4, wherein: The predetermined limit value defines the maximum rate of fluid removal per unit body weight.

6. The dialysis machine according to claim 4 or 5, wherein: The controller (13) is configured to obtain the current weight by prompting the user to input the current weight through the user interface (14).

7. The dialysis machine according to any one of claims 4 to 6, wherein: The controller (13) is configured to obtain the current weight only when the selected size falls within a specific size range.

8. The dialysis machine according to claim 7, wherein: The particular size range is representative of blood tubing used for pediatric dialysis.

9. The dialysis machine according to any one of claims 6 to 8, wherein: The controller (13) comprises: a first module (13a) configured to execute the configuration process (400); and a second module (13b) configured to estimate the treatment efficiency of the extracorporeal blood treatment based on conductivity data from a sensor device (19a, 19b) in the dialysis machine, wherein the second module (13b) is operable to allow the current body weight to be input through the user interface (14), wherein the first module (13a) is configured to obtain the current body weight by using the second module (13b).

10. The dialysis machine according to any one of claims 4 to 9, wherein: The configuration data (CD) further associates the different sizes with corresponding weight ranges, and wherein the controller (13) is further configured to evaluate the current weight relative to the weight range associated with the selected size of the blood line (6) and to present a weight alert on the user interface (14) if the current weight deviates from the weight range.

11. The dialysis machine according to any one of the preceding claims, wherein The controller (13) is further configured to present the maximum rate on the user interface (14).

12. The dialysis machine according to any one of the preceding claims, wherein: The controller (13) is also configured to determine a selected rate of fluid removal for the extracorporeal blood treatment based on input data obtained through the user interface (14), evaluate the selected rate relative to the maximum rate, and present a rate alarm on the user interface (14) if the selected rate exceeds the maximum rate.

13. A dialysis system according to any one of the preceding claims, wherein: The first pumping device comprises a peristaltic pump (15), and wherein the different sizes correspond to different inner diameters of a portion (6') of the blood line (6) configured to engage with one or more rollers (152, 154) of the peristaltic pump (15).

14. A computer-implemented method of configuring a dialysis machine to perform extracorporeal blood treatment, the dialysis machine comprising: user interface; a first pumping device configured to interface with a disposable blood line in fluid communication with a first compartment of a dialyzer, the blood line being available in at least two different sizes; and a second pumping device configured to interface with a line set in fluid communication with a second compartment of the dialyzer, the second compartment being separated from the first compartment by a semipermeable membrane, the second pumping device being operable to control fluid removal from blood in the first compartment through the semipermeable membrane during the extracorporeal blood treatment, the computer-implemented method comprising: obtaining (402) dimensional data indicating a selected dimension of the blood line associated with a patient for use in the extracorporeal blood treatment; retrieving (403) configuration data from a memory, the configuration data associating different sizes of the blood lines with corresponding predetermined limits for fluid removal; determining (403) a maximum rate of removal of the fluid from the blood based on the selected size using the configuration data; and The dialysis machine is configured (404) to maintain the fluid removal below the maximum rate during the extracorporeal blood treatment.

15. A computer readable medium comprising computer instructions which, when executed by a processor (131), cause the processor (131) to perform the method of claim 14.

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