Medical blood treatment apparatus for extracorporeal blood treatment and method for priming an extracorporeal blood tubing set on a blood treatment apparatus

By using an automated pre-filling method in a blood processing device, which utilizes a computer program to control the blood pump and a touchscreen interface, the problems of air entering the blood tubing and wasting pre-filling fluid are solved, achieving a safe and efficient pre-filling process and reducing costs and resource waste.

CN122396512APending Publication Date: 2026-07-14FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH
Filing Date
2024-12-12
Publication Date
2026-07-14

AI Technical Summary

Technical Problem

Existing technologies for extracorporeal blood processing pose a risk of unintentional air entering the blood tubing, and the pre-filled liquid has low utilization efficiency, leading to resource waste and increased costs.

Method used

An automatic pre-filling method is adopted. Through the control and regulation device of the blood processing unit, the blood pump is controlled by a computer program to deliver pre-filled liquid in the extracorporeal blood tubing. Combined with a touch screen user interface, it realizes the combination of automatic and manual steps, ensuring that air does not enter the tubing and optimizing the use of liquid.

Benefits of technology

It effectively prevents air from entering the blood tubing, reduces waste of prefilled fluid, improves resource utilization efficiency, lowers costs, and simplifies operating procedures.

✦ Generated by Eureka AI based on patent content.

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Abstract

A medical blood treatment apparatus for extracorporeal blood treatment and a method for priming an extracorporeal blood tubing set on the blood treatment apparatus are presented to enable a user to prime the extracorporeal blood tubing set with a priming liquid from a liquid container while completely emptying the liquid container, wherein at the same time the unintentional introduction of air into the extracorporeal blood tubing set shall be avoided. After a first step of an automatic priming with a partial amount of the priming liquid, a user-controlled selection of a manual continuation of the priming as a second step is enabled to completely empty the liquid container.
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Description

Technical Field

[0001] This invention relates to a preparatory step before initiating extracorporeal blood processing, which involves filling the blood lines on a blood processing device for extracorporeal blood processing with pre-filled liquid from a liquid container. Background Technology

[0002] Various methods for prefilling extracorporeal blood lines are known. In one prefilling method, particularly known from the multiFiltratePRO blood processing device of the applicant Fresenius Medical Care Deutschland GmbH, a liquid container with prefilled liquid is connected to an arterial patient connector of the extracorporeal blood line, which is a disposable line, and an empty waste bag is connected to a venous patient connector of the extracorporeal blood line. The prefilled liquid is pumped from the liquid container through the extracorporeal blood line, which includes a blood processing module, into the waste bag by means of a blood pump. During this process, air is expelled from the extracorporeal blood line, and any possible residues from production and sterilization are flushed away.

[0003] Disposable tubing is understood as a tubing system configured for single-use, single-use, or disposable purposes, or tubing disposed of or discarded after a single use. In specialized blood processing devices for continuous extracorporeal blood treatment (CKRT) or for acute extracorporeal blood treatment in intensive care units (ICUs), the dialysate tubing or filtrate tubing is also implemented as disposable, similar to the extracorporeal blood circuit, and the required medical solutions, such as dialysate and replacement fluid or substitutes, as well as pre-filled fluids, are provided as prepared solutions in solution bags. Such disposable tubing, such as extracorporeal blood tubing, is externally connected by the user to the functional interface of the blood processing device before extracorporeal blood treatment. In this case, among other things, sections of the extracorporeal blood tubing, particularly the pump section, are inserted into the tubing receiving area of ​​a blood pump, which is located on the outer surface of the blood processing device and is accessible from the outside. Summary of the Invention

[0004] One object of the present invention is to prevent air from being unintentionally introduced into the extracorporeal blood tubing during the pre-filling of the extracorporeal blood tubing.

[0005] Another object of the present invention is to enable users to pre-fill the extracorporeal blood tubing with pre-filled liquid from a liquid container while completely emptying the liquid container, thereby preventing the unintentional introduction of air into the extracorporeal blood tubing.

[0006] Another objective is to propose an alternative method and apparatus for prefilling extracorporeal blood tubing assemblies, wherein this implementation can be achieved solely through a software update in the control of the extracorporeal blood processing device. For example, for cost reasons, the use of conceivable weighing devices, such as those used for more accurate measurement of the current volume of liquid in the container, or equally conceivable level measurements of the container using sensors, should be avoided, while simultaneously improving patient safety.

[0007] Another objective is to avoid excessive amounts of unused pre-filled liquid that must be discarded. This achieves both ecological advantages and cost savings.

[0008] Another objective is to avoid consuming excessive amounts of pre-filled liquid containers compared to the actual volume of pre-filled liquid required. This achieves both ecological advantages and cost savings.

[0009] Another objective is to avoid the time wasted on suspending and connecting too many pre-filled liquid containers by suspending and connecting only the minimum number of pre-filled liquid containers corresponding to the required amount of pre-filled liquid.

[0010] The present invention relates to a blood processing apparatus for extracorporeal blood processing having the features of claims 1 to 8, and a method for prefilling an extracorporeal blood tubing assembly having the features of claims 9 to 14.

[0011] The objective according to the invention is achieved by the features of independent claims 1 and 9. Advantageous embodiments are the subject of the dependent claims. The advantages of the blood processing apparatus according to claim 1 can be achieved overall by the method according to claim 9.

[0012] The method for pre-filling an extracorporeal blood tubing assembly according to the invention begins with automatic pre-filling, hereinafter referred to as the "first step," which is controlled by a control and regulation device by means of a computer program, and particularly requires no user operation during pre-filling. Following the "first step," the method according to the invention has steps that are at least partially performed manually by the user, hereinafter referred to as the "second step."

[0013] The blood processing apparatus according to the invention has a machine housing and a control and regulation device for controlling and regulating extracorporeal blood processing, the control and regulation device being particularly electronic.

[0014] The blood processing device according to the invention has a display screen user interface, which is a graphical user interface (GUI) implemented as a touchscreen. The touchscreen has a bidirectional signal connection to the control and adjustment device, enabling the display of graphical and textual notifications on the touchscreen and the transmission of user input to the control and adjustment device via input buttons (e.g., confirmation buttons). Actuation of the input buttons can be or includes manual actuation, for example, by tapping or pressing with a finger (e.g., once or multiple times), or by maintaining a tapping or pressing state.

[0015] The blood processing device has at least one blood pump configured to deliver blood into at least one blood line to be connected for extracorporeal blood processing. The blood line to be connected may be part of a disposable tubing assembly. The control and regulation device is signal-connected to the blood pump.

[0016] The blood pump can be a peristaltic pump, particularly a peristaltic roller pump. The blood pump is configured to accommodate a blood line pump section of the blood tubing.

[0017] The blood pump has an electrically driven motor, wherein the stator and rotor of the blood pump are external to the machine housing and accessible to the user. The control and regulation device is signal-connected to the electrically driven motor.

[0018] The control and adjustment device has one or more CPUs (central processing units) and a memory for storing computer programs. When the computer program runs, it executes automatic steps of the pre-charging method according to the invention, provides user guidance on the touchscreen for performing manual steps, and processes user input on the touchscreen that is necessary for performing the manual steps.

[0019] The machine housing has at least one means for suspending at least one liquid container, particularly an infusion rod with at least one hook, the liquid container being able to be suspended on the hook, the liquid container being filled with a pre-filled liquid of a specified initial volume.

[0020] The specified initial volume of pre-filled liquid in the liquid container to be used by the user is input or selected as a parameter during the setup process via a graphical user interface (GUI). This input can be performed by the user or specified in the control and regulation device. This value may vary depending on the specific method, and may be, for example, 1000 ml, 2000 ml, or 3000 ml, particularly 1000 ml.

[0021] The liquid container may in particular be a solution bag having at least one outlet. This solution bag is, in particular, made of plastic film.

[0022] The blood lines to be connected for extracorporeal blood processing can be selected from the following group: removal lines, arterial lines, return lines, and venous lines.

[0023] Since the control and regulation device is able to run computer programs in its memory, the objectives according to the invention can be achieved by only software changes, without the need for hardware modifications to the blood processing device.

[0024] Optionally, the machine housing has a base with four casters, allowing the machine housing to stand upright on the ground with its casters and to be pushed to another position by the user or rotated about its vertical axis to an ergonomic working position.

[0025] According to the present invention, an automatic partial emptying of the liquid container as a "first step" is proposed, wherein, for safety reasons, the automatic partial emptying is automatically stopped in time before the liquid container is completely emptied, so that initially a residue of pre-filled liquid, such as 5% of the pre-filled liquid, remains in the liquid container.

[0026] In order to perform the method according to the invention, standardized liquid containers with pre-filled liquid, known from the prior art, are used. These containers are each pre-filled in an aseptic manner with a specified volume of pre-filled liquid, particularly physiological NaCl solution, for example, 1000 ml of physiological NaCl solution.

[0027] During blood pump operation, the actual delivery rate may deviate from the target delivery rate in practice, for example, by as much as + / - 5%. This actual delivery rate depends on a number of influencing variables, which are often unknown and unmeasured, and the deviation is usually imperceptible.

[0028] The blood pump of the blood processing apparatus according to the invention is actuated at a specified target delivery rate, such that only a portion of the pre-filled liquid from the liquid container is automatically delivered into the extracorporeal blood tubing, for example, only 95%. The control and regulation device continuously determines the calculated volume of the pre-filled liquid being delivered during the first step, and stops the blood pump once the volume of liquid delivered first reaches or exceeds a specified first limit.

[0029] Therefore, for a specified volume of 1000 ml, for example, only 950 ml from the liquid container is automatically delivered into the extracorporeal blood tubing, leaving 50 ml of residue in the liquid container. A first limit is defined in the control and regulation device for the portion of the pre-filled liquid to be automatically delivered. This first limit is always less than the initial volume of pre-filled liquid in the liquid container and can be determined, for example, as follows: For instance, the first limit can be automatically calculated by the controller based on a specified initial volume of pre-filled liquid and a specified factor "f" that takes into account the expected inaccuracies of the pump; for example, f = 0.95, i.e., 95% of the initial volume. That is, in this example, the first limit is 950 ml.

[0030] If the blood pump actually delivers at a rate higher than the specified target delivery rate, when delivering pre-filled fluid from a 1000ml bag, the blood pump will continue to operate additionally after 1000ml has actually been delivered from the bag until the computer in the control and regulation device detects that 1000ml has been delivered according to the specified target delivery rate. In this case, the blood pump will evacuate part of the bag and tubing, and simultaneously create a significant negative pressure on its suction side and in the empty bag, thereby posing the risk that air will imperceptibly seep in from the surrounding environment, for example, through the arterial patient connector, for example, if the arterial patient connector is unintentionally not screwed tightly enough onto the connector of the fluid container, or through other possible leaks. This is prevented by the "first step" according to the invention. On the other hand, if the blood pump actually delivers at a rate lower than the specified target delivery rate, pre-filled fluid residue will remain in the bag anyway, which also satisfies the purpose of the first step.

[0031] The control and regulation device actuates the blood pump in the "first step" such that, under no circumstances will it operate at a sufficient number of revolutions to automatically and completely empty the liquid container, or even exceed that level.

[0032] According to the invention, this first step prevents the blood pump from drawing in air from the surrounding environment through leakage and delivering it to the extracorporeal blood circuit.

[0033] The volume of the pre-filled liquid to be delivered can be determined using various calculation methods, for example: 1. In some embodiments, the control and regulation device may be configured to calculate the calculated volume of pre-filled fluid delivered during a “first step” by progressively accumulating a specified target delivery rate of the blood pump over the operating time of the blood pump. This target delivery rate may, for example, have units of “milliliters per unit time.” A characteristic curve or feature map of the target delivery rate of the blood pump as a function of possible other influencing variables, such as characteristics of the pump tubing or correction factors, may optionally be stored in the control and regulation device.

[0034] 2. In some other embodiments, the control and regulation device may be configured to calculate the calculated volume of pre-filled fluid delivered during a “first step” by progressively accumulating a specified target delivery volume per rotor revolution of the blood pump over the measured revolutions of the roller pump rotor. For this purpose, the revolutions of the roller pump rotor are progressively measured using at least one magnet on the pump rotor and at least one Hall sensor on the pump stator, and evaluated progressively within the control and regulation device. For example, full revolutions (360°) or half revolutions (180°) can be recorded and counted using two diagonally opposite magnets on the pump rotor and one Hall sensor on the pump stator. A characteristic curve or feature map for the specific target delivery volume per rotor revolution of the blood pump as a function of possible other influencing variables, such as characteristics of the pump tubing or correction factors, may optionally be stored in the control and regulation device. The specific target delivery volume of the blood pump may, for example, have the unit “milliliters per revolution”.

[0035] 3. In some other embodiments, the control and regulation device may be configured to determine, during the “first step”, a calculated volume of pre-filled fluid to be delivered by progressively accumulating a specified target delivery volume for each rotation angle or rotation angle step of the blood pump over the rotation angles performed by the rotor during the operation time of the blood pump. For this purpose, characteristic curves or characteristic maps relating the specific target delivery volume per rotation angle or rotation angle step of the blood pump to other possible influencing variables, such as characteristics of the pump tubing or correction factors, may be stored in the control and regulation device. This embodiment is particularly advantageous if the electric drive motor of the blood pump is a stepper motor, which can perform defined rotation angles or rotation angle steps.

[0036] 4. In some embodiments, the control and regulation device may be configured to progressively calculate the delivery rate of the blood pump during a “first step” by progressively recording the actuation voltage of the electric drive motor of the blood pump, and progressively accumulate the calculated delivery rate of the blood pump over the operating time of the blood pump to determine the calculated volume of pre-filled fluid delivered. For this purpose, a characteristic curve or characteristic graph of the relationship between the actuation voltage of the motor drive and the delivery rate may be stored in the control and regulation device, optionally depending on other possible influencing variables (such as the characteristics of the pump tubing or correction factors).

[0037] 5. In other embodiments, the control and regulation device may be configured to combine two or more of the above methods to calculate the calculated volume of the pre-filled liquid delivered during the "first step". For example, this can enable confidence checks and improve reliability.

[0038] If the prefilling process for preparing for a specific treatment method requires more than one single standardized liquid container, for example, since the method specifies a prefill volume of 2000 ml, repeating the first step and using a new liquid bag each time, each liquid bag having 1000 ml of prefill liquid, will result in, for example, 5% unused residue remaining in the first liquid container, and another 5% unused residue remaining in the next liquid container with 1000 ml of prefill liquid. Thus, to reach the specified 2000 ml prefill volume, 10% is still missing, and even a third liquid container may be needed to reach the specified 2000 ml prefill volume, where even 90% of the unused residue may remain.

[0039] Therefore, the standalone "first step" has the disadvantage that, without the "second step" according to the method of the invention, the partially emptied liquid container must be discarded. According to the invention, at least a "second step" for completely emptying the pre-filled liquid residue from the liquid container is thus provided, wherein the "second step" can be manually initiated by the user. The user can see how much of the liquid container has been emptied after the "first step".

[0040] Therefore, the liquid container is preferably a flexible liquid bag, such as one of the known NaCl solution bags. The liquid container is preferably transparent in at least certain sections, allowing the user to observe the liquid level. The tube is also transparent.

[0041] According to the invention, a "second step" for manually emptying the pre-filled liquid residue from the liquid container is performed using user guidance provided by the controller of the blood processing device via the display screen user interface of the blood processing device, particularly via the touch screen of the blood processing device. For this purpose, a text prompt is displayed on the touch screen by means of the controller of the blood processing device, informing the user that, after automatic partial emptying, the liquid container containing the pre-filled liquid can optionally be completely emptied in a user-controlled manner. The controller of the blood processing device according to the invention provides at least one input button on the touch screen of the display screen, particularly a confirmation button with a "User-controlled Residual Emptying" button and an optional "No User-controlled Residual Emptying, Residual Liquid Discarded" button, via which the user can perform or reject the option of user-controlled residual emptying. User-controlled emptying of the pre-filled fluid requires brief user attention, as the user must observe the drop in the pre-filled fluid level during this process. User-controlled emptying should cease once the fluid container is completely emptied, specifically by manually entering a command on the touchscreen to stop the blood pump when it is visually identifiable that the container is completely empty or the pre-filled fluid level has reached a point below the outlet opening in the tubing section. In particular, when the user observes that the pre-filled fluid level has reached the outlet connection of the fluid container or the height in the transfer line, the user can enter a command on the touchscreen to stop the delivery unit, particularly the blood pump.

[0042] If users do not have time to perform user-controlled evacuation of residual blood, they can reject the option by activating the optional "No User-Controlled Evacuation" button, accepting the aforementioned drawbacks. This is particularly relevant in intensive care units where users often need to focus on multiple tasks simultaneously and prioritize them. One of the many possible examples is when, during the setup of a planned blood processing unit, an alarm is triggered by blood processing on another unit in the same room, requiring action, and the user must prioritize tasks according to importance. Therefore, the optional "No User-Controlled Evacuation" button prevents excessive distraction of the user's attention in critical situations.

[0043] The target delivery rate of the blood pump can optionally be specified smaller for the "second step" than for the "first step," thereby enabling visual monitoring of the pre-filled fluid level in the "second step" in a particularly user-friendly manner, and allowing the user to promptly input a command to stop the blood pump.

[0044] The control and regulation device can provide specified termination criteria for the "second step," specifically a second limit for the delivery volume of the pre-filled liquid. If the second limit is reached or exceeded for the first time, the control and regulation device automatically shuts off the blood pump for safety reasons, without user intervention. This prevents the user from mistakenly continuing to run the blood pump when the liquid container is clearly empty.

[0045] The medical blood processing device for extracorporeal blood processing using an extracorporeal blood tubing assembly with a blood processing module comprises: at least one means for suspending at least one liquid container filled with a pre-filled liquid of a specified initial volume; and at least one blood pump having a rotor and a motor driver, the at least one blood pump being configured to functionally connect a tubing section of the extracorporeal blood tubing assembly, particularly a pump section, wherein the blood pump has means for recording the number of revolutions and / or the rotation angle of the rotor.

[0046] Examples of the blood processing modules are dialyzers, blood filters, hemodialysis filters, membrane gas exchangers, and adsors.

[0047] The medical blood processing device includes a control and regulation device with a memory and a display screen with a touchscreen, the touchscreen being signal-connected to the control and regulation device. The control and regulation device is programmed to display a graphical output interface for text and / or visual representation, and at least one first input button and a second input button. The at least one first input button is used to initiate the automatic delivery of the pre-filled fluid via the blood pump. The control and regulation device is signal-connected to the motor driver to actuate the motor driver using an actuation voltage during the operation of the blood pump. The device is signal-connected to a means of recording the number of revolutions and / or rotation angle of the rotor, and is programmed to control and / or adjust the blood pump at a specified target delivery rate for delivering pre-filled fluid in the extracorporeal blood tubing assembly, wherein the control and adjustment means is programmed to progressively determine and store the cumulative volume of the delivered pre-filled fluid based on (i) the operating time of the blood pump or (ii) the number of revolutions performed by the rotor or (iii) the angle of rotation performed by the rotor or (iv) the actuation voltage of the motor driver, and is also able to store a specified initial volume of the pre-filled fluid in the liquid container.

[0048] The control and regulation device is additionally programmed to store in the memory a specified first limit value for a first portion volume of the pre-filled liquid, the first limit value being less than the initial volume of the pre-filled liquid in the liquid container, and to actuate the blood pump to automatically deliver the pre-filled liquid at a specified target delivery rate when actuation of a first input button is detected, and to stop the automatic delivery of the pre-filled liquid when the determined cumulative volume of the delivered pre-filled liquid first reaches or exceeds the specified first limit value, and to display at least a second input button on the touch screen, and to display a user prompt on the graphical output interface by means of text and / or visual representation indicating that the delivery of the pre-filled liquid can be continued manually by actuation of the second input button, and to restart the delivery of the pre-filled liquid by means of the blood pump when actuation of the second input button is detected.

[0049] When actuation of the first input button is detected, this is assessed as user confirmation that the pre-filled fluid container is connected to the extracorporeal blood tubing assembly in a fluid-conducting manner, and that the delivery of the pre-filled fluid via a blood pump can be initiated. A user prompt on the graphical output interface notifies the user of this status.

[0050] In some embodiments, the medical blood processing device is further characterized in that the control and regulation device is additionally programmed to automatically and completely terminate precharging when no actuation of the second input button is detected within a specified time limit.

[0051] In some embodiments, the medical blood processing device additionally has the following features: the control and regulation device is additionally programmed to display a third input button on the touchscreen when the automatic delivery of the pre-filled fluid stops, and to display a user prompt on the graphical output interface via text and / or visual representation, indicating that actuating the third input button (i) can completely terminate the pre-filling, or (ii) can refuse, skip, or end the manual continuation of the pre-filled fluid delivery by actuating the third input button, and that when actuation of the third input button is detected, it can (i) completely terminate the pre-filling, or (ii) refuse, skip, or end the manual continuation of the pre-filled fluid delivery. This advantageously enables immediate and complete termination of pre-filling, or (ii) immediate refusal, skipping, or end of the manual continuation of the pre-filled fluid delivery. Optionally, the control and regulation device may be additionally programmed to automatically and completely terminate the pre-filling if no actuation of the third input button is detected within a specified time limit. This advantageously allows the precharge to end in a clearly defined manner if no actuation of the third input button is detected, especially if the user ignores the third input button.

[0052] Depending on the treatment method to be implemented and the required extracorporeal blood tubing and / or blood processing module, different amounts of prefilled fluid may be required, thus, for example, more than one liquid container with prefilled fluid may be needed. In some embodiments, the medical blood processing device is additionally characterized in that the control and regulation device is additionally programmed to display a fourth input button on the touchscreen and to additionally display user prompts on the graphical output interface via text and / or visual representations indicating that actuation of the fourth input button can initiate the delivery of prefilled fluid from another liquid container filled with a specified initial volume of prefilled fluid, and that actuation of the fourth input button actuates the blood pump to deliver the prefilled fluid at a specified target delivery rate.

[0053] Actuation of the fourth input button is evaluated as user confirmation that another liquid container with pre-filled liquid is connected to the extracorporeal blood tubing assembly in a liquid-conducting manner.

[0054] The fourth input button is particularly visible when the automatic delivery of the pre-filled liquid stops and / or when manual continuation of the pre-filled liquid has been rejected, skipped, or terminated.

[0055] According to the invention, the control and regulation device is programmed such that a first limit stored in the memory is 1% to 10% smaller than the initial volume of pre-filled liquid in the liquid container, preferably 3% to 7%, and particularly preferably 4% to 6%. This ensures a sufficiently large safety distance between the pre-filled liquid and the initial volume of pre-filled liquid in the liquid container, and prevents uncontrolled automatic continuation of pre-filled liquid from the liquid container and the ingress of air.

[0056] Various algorithms for delivering pre-filled liquid when the second input button is actuated are disclosed exemplarily, and these algorithms are particularly user-friendly and therefore advantageous.

[0057] In some embodiments, the medical blood processing device is further characterized in that the control and regulation device is additionally programmed to continue the delivery of the pre-filled liquid as long as continued actuation of the second input button is detected after actuation of the second input button is detected, and to stop the delivery of the pre-filled liquid when the second input button is no longer actuated. The user can keep the input button actuated while observing the liquid level in the liquid container, as long as they wish to deliver the pre-filled liquid. Releasing the second input button immediately stops the delivery of the pre-filled liquid. Advantageously, the user does not need to take their eyes off the liquid level in the liquid container, and can stop the delivery of the pre-filled liquid very quickly when the liquid container is identifiable as empty. This advantageously avoids the user performing manual delivery of the pre-filled liquid for an extended period.

[0058] In other embodiments, the medical blood processing device is characterized in that the control and regulation device is additionally programmed to continue the delivery of the pre-filled liquid for a predetermined interval after detecting actuation of the second input button, and to always resume the delivery of the pre-filled liquid at the predetermined interval when actuation of the second input button is detected again, wherein the predetermined interval is defined by a stop criterion selected from the group consisting of: (i) a specified rotor speed n = 1 to 10 or a specified rotation angle, or (ii) a specified delivery volume from a numerical range V = 1 ml to 50 ml, or (iii) a specified time interval from a numerical range t = 1 second to 10 seconds. In other words, the user can perform the delivery of the pre-filled liquid in multiple small automatic steps by repeatedly tapping the second input button. Advantageously, the user can easily and intuitively see whether another interval is still needed before the liquid container can be identified as empty. This advantageously avoids the user performing manual delivery of the pre-filled liquid for too long.

[0059] Optionally, a smaller target delivery rate for the blood pump can be specified within predetermined intervals, allowing the user to advantageously identify, in a particularly intuitive and easy manner, whether another interval is needed before the fluid container can be identified as empty. In other words, the predetermined interval can correspond to the delivery of one bolus of pre-filled fluid. The user can continuously deliver or meter multiple boluses of pre-filled fluid.

[0060] In some embodiments, the medical blood processing device is additionally characterized in that the control and regulation device is additionally programmed to store a specified second limit value for the maximum permissible volume of the total pre-filled fluid to be delivered, and to automatically and completely terminate pre-filling once the volume of the pre-filled fluid delivered first reaches or exceeds the specified second limit value. This advantageously automatically avoids prolonged manual delivery of pre-filled fluid due to user error. The maximum permissible volume of the total pre-filled fluid to be delivered may, for example, correspond to the sum of the initial volume of the pre-filled fluid in the liquid container and a portion of the volume in the transfer tubing.

[0061] The blood treatment apparatus according to the present invention can be selected from the group consisting of: hemodialysis machine, hemofiltration machine, hemodiafiltration machine, acute dialysis machine, CRRT machine, CKRT machine, and apheresis machine. CRRT is an earlier abbreviation for "Continuous Renal Replacement Therapy," while CKRT is a more recent abbreviation for "Continuous Kidney Replacement Therapy."

[0062] Using the medical blood processing device according to the invention, a user can perform the method according to the invention for pre-filling an extracorporeal blood tubing assembly on the blood processing device. The method according to the invention includes the following steps: A medical blood processing device according to the present invention is provided, a liquid container filled with a pre-filled liquid of a specified initial volume, and an extracorporeal blood tubing assembly having a blood processing module.

[0063] The user suspends the at least one liquid container pre-filled with liquid on at least one suspension device, particularly on an infusion pole, and functionally connects the tubing sections of the extracorporeal blood tubing assembly, particularly the pump tubing sections, to the blood pump. In the case of a roller pump, functional connection means, for example, inserting the pump tubing section into the blood pump so that the blood pump can deliver the liquid contents of the pump tubing section. This functional connection is, for example, made during the assembly of the blood processing device before initiating extracorporeal blood processing.

[0064] Users connect the liquid container to the tubing of the extracorporeal blood tubing system via a liquid-conducting connection.

[0065] The control and adjustment device displays a graphical output interface for text and / or visual representation and at least one first input button on a touch screen.

[0066] When the expression "detection of actuation of an input button" is selected in this disclosure, it always means that the control and adjustment unit receives a signal from the touchscreen that the corresponding input button has been touched or clicked on the touchscreen. The touch or click is intended to be performed manually by the user, for example, with one of their fingers.

[0067] The control and regulation device detects actuation of the first input button and subsequently actuates the delivery unit, particularly the blood pump, to automatically deliver pre-filled fluid. When the determined volume of the delivered pre-filled fluid first reaches or exceeds a specified first limit, the automatic delivery of the pre-filled fluid is stopped. At least the second input button and the user prompt are displayed on the graphical output interface of the touchscreen, indicating that the delivery of the pre-filled fluid can be continued manually by actuating the second input button. The delivery of the pre-filled fluid is restarted when actuation of the second input button is detected.

[0068] When actuation of the first input button is detected, this is assessed as user confirmation that the pre-filled fluid container is connected to the extracorporeal blood tubing assembly in a fluid-conducting manner, and that the delivery of the pre-filled fluid via a blood pump can be initiated. The control and regulation device can display user prompts and notify the user on the graphical output interface.

[0069] In some embodiments, the method for precharging includes an additional step: when no actuation of the second input button is detected within a specified time limit, the precharging is automatically and completely terminated by the control and adjustment device.

[0070] In some embodiments, the method for pre-charging includes the following additional steps of the control and regulation device: after the automatic delivery of pre-charged liquid stops, additionally displaying a third input button and additionally displaying a user prompt on a graphical output interface on a touch screen, indicating that pre-charging can be completely terminated by actuating the third input button, or (ii) manual continuation of pre-charged liquid delivery can be rejected, skipped, or ended by actuating the third input button, and if actuation of the third input button is detected, then (i) pre-charging is completely terminated, or (ii) manual continuation of pre-charged liquid delivery is rejected, skipped, or ended, and / or automatic pre-charging is completely terminated if actuation of the third input button is not detected within a specified time limit.

[0071] In some embodiments, the pre-charging method includes the following additional steps of the control and regulation device: continuing the delivery of the pre-charge liquid as long as continuous actuation of the second input button is detected, and stopping the delivery of the pre-charge liquid when the second input button is no longer actuated.

[0072] In some other embodiments, the method for pre-charging includes the following additional steps of the control and regulation device: when actuation of the second input button is detected, continuing the delivery of the pre-charged liquid for a predetermined interval, and when re-application of the second input button is detected, always resuming the delivery of the pre-charged liquid at the predetermined interval. The predetermined interval is defined herein by a stop criterion selected from the group consisting of: (i) a specified rotor speed n = 1 to 10 or a specified rotation angle, or (ii) a specified delivery volume from a numerical range V = 1 ml to 50 ml, or (iii) a specified time interval from a numerical range t = 1 second to 10 seconds.

[0073] In some embodiments, the method for pre-charging includes an additional step of the control and regulation device: automatically and completely terminating pre-charging once the volume of the pre-charged liquid delivered first reaches or exceeds a specified second limit. Attached Figure Description

[0074] Figure 1 A schematic diagram of an extracorporeal blood circuit is shown.

[0075] Figure 2 A view of an exemplary blood processing device for extracorporeal blood processing is shown.

[0076] Figure 3 A schematic diagram of an exemplary embodiment of a disposable tubing assembly for extracorporeal blood processing is shown.

[0077] Figure 4 A schematic diagram of an exemplary embodiment of a liquid container with pre-filled liquid suspended on an infusion pole is shown.

[0078] Figure 5 It shows Figure 2 The diagram shows the upper section of the blood processing device during pre-filling according to the present invention.

[0079] Figure 6 A flowchart illustrating an embodiment of the method according to the present invention is shown. Detailed Implementation

[0080] An exemplary embodiment of the blood processing apparatus according to the present invention will now be described in more detail with reference to the accompanying drawings. Further details and advantages of the invention will be described in more detail based on the exemplary embodiments described in the drawings. Reference numerals in the drawings have the same meaning throughout all the drawings. The method according to the present invention can be performed using the blood processing apparatus according to the present invention.

[0081] Figure 1 A schematic diagram of an extracorporeal blood circuit is shown. The extracorporeal blood circuit has a removal line or arterial blood line 1260 with a blood pump 1210, by means of which blood is drawn from the patient's vascular access and guided into the blood chamber of a dialyzer or blood filter 1250. Blood is guided from the blood chamber 1260 back into the patient's vascular access by means of a return line or venous line 1270 with a bubble separator or venous chamber 1284. The patient-side ends of the removal line or arterial blood line 1260 and the return line or venous line 1270 are respectively equipped with a removal clip or arterial clip 1261 or a return clip or venous clip 1271, by means of which the flow can be interrupted by clamping the line by a machine-side actuator. The patient-side end of the removal line or arterial blood line 1260 has an arterial patient connector 1261a, and the return line or venous line 1270 has a venous patient connector 1271a. Patient connectors 1261a and 1271a are configured to connect to complementary connector halves of a central venous catheter or arterial and venous cannula, which establishes access to the patient's vascular system. Patient connectors 1261a and / or 1271a can also be used to connect to a pre-filled liquid container, wherein the outlet of the liquid container has a matching complementary connector half.

[0082] Taking a dialyzer or blood filter 1250 as an example, it is internally divided into a blood chamber and a dialysate chamber or filtrate chamber by a semipermeable membrane 1251. This dialyzer or blood filter is selected here as an example of a blood processing module. In the case of hemodialysis, the dialysate chamber is supplied with dialysate by means of a dialysate pump 1220 in the dialysate line, the dialysate being disposed in a dialysate container 1282. The dialysate may be heated in a dialysate heating bag 1283 on its path to the dialysate chamber. During hemodialysis, the substance to be separated from the blood diffuses from the blood into the dialysate chamber through the semipermeable membrane. The dialysate containing the substance to be separated and to be discarded is discharged into the dialysate container 1285 by means of a dialysate pump 1240 in the medical line 3000. In the case of convective hemofiltration only, the filtrate enters the filtrate chamber 1253 from the blood chamber through the semipermeable membrane. During hemodialysis filtration, using a method that combines diffusion and convection, the filtrate also passes through a semipermeable membrane from the blood chamber into the filtrate chamber 1253, and is then pumped to the filtrate container 1285 by means of the filtrate pump 1240 in the medical line 3000. The waste fluid in the medical line 3000, whether referred to as dialysate, filtrate, or simply as discharge, flows through the tubing section 3100, on which an optical blood leak detector 1295 is arranged. The waste fluid is then collected in the dialysate container, filtrate container, or discharge container 1285 for disposal. In this invention, the terms dialysate, filtrate, and discharge are used synonymously for the fluid to be disposed of, because in this invention, it is not important which blood treatment method is used to obtain the fluid to be disposed of. The optical blood leak detector 1295 detects blood or blood components in the dialysate, filtrate, or discharge with a specific sensitivity, while the fluid flows through the tubing section 3100 at a specific flow rate. In some embodiments, the extracorporeal blood circuit may have various pressure measurement points, namely a pressure measurement point 1290 located upstream of the blood pump, a pressure measurement point 1291 located downstream of the blood pump, and a pressure measurement point 1293 located on the return line or venous line 1270, particularly located at the bubble separator or venous chamber 1284. In some embodiments, a replacement fluid line may be additionally provided, comprising a replacement fluid container 1280, a replacement fluid pump 1230, and a replacement fluid heating bag 1281. Figure 1 In this example, a replacement fluid line is shown on the return line or venous line 1270. Alternatively or additionally, another replacement fluid line with a corresponding arrangement of another replacement fluid container, another replacement fluid pump, and another replacement fluid heating bag may be provided on the removal line or arterial line 1260.

[0083] Figure 2 A schematic perspective view of a blood processing apparatus 1000 for extracorporeal blood processing according to the present invention is shown.

[0084] Figure 2The diagram schematically shows a dialysis fluid pump 1220, a replacement fluid pump 1230, a filtrate pump or drain fluid pump or dialysis fluid pump 1240, and a blood pump 1210 at the front of a blood processing device 1000. The dialysis fluid pump 1220 is configured to functionally connect to a dialysis fluid pump tubing section 1221. Figure 2 (Not shown in the image), the displacement fluid pump 1230 is configured to functionally connect to the displacement fluid pump line section 1231 (also in... Figure 2 (Not shown in the image), the filtrate pump or discharge pump or dialysate pump 1240 is configured to functionally connect to the filtrate pump tubing section 1241 (also in... Figure 2 (Not shown in the image), the blood pump 1210 is configured for functional connection to the blood line pump section 1262 (also in... Figure 2 (Not shown in the image). The pump section described above is a component of the disposable pipe assembly 4000 (see [reference]). Figure 3 ).

[0085] In a specific embodiment of the disposable tubing assembly 4000 according to the present invention (see...) Figure 3 The disposable tubing assembly 4000 can be pre-assembled in or on a organizer or tray for easy functional connection. The functional connection of the disposable tubing assembly 4000 according to the invention (also referred to by the user as the assembly process) in such embodiments begins by manually suspending the organizer or tray on two hooks or pins 1500a and 1500b at the front of the blood processing device 1000. All tubing components to be functionally connected are thus suspended in a user-friendly manner in front of the assigned machine-side actuators and sensors. For example, the pump segment of the arterial line 1260 is arranged by means of a tray or organizer, such that the blood line pump segment 1262 is suspended directly in front of the blood pump 1210 in a user-friendly manner. This avoids errors caused by incorrectly mixing tubing segments during assembly and achieves a particularly fast and user-friendly assembly process, which is especially important for critical care or emergency medicine in intensive care units.

[0086] In certain embodiments, additional pumps may be provided, such as a heparin pump for heparin anticoagulation and / or local anticoagulation, a citrate pump for pumping citrate-containing medical solutions, and a calcium pump for pumping calcium-containing medical solutions. In such embodiments, the disposable tubing 4000 additionally includes: at least one heparin line leading to an arterial blood line or a removal line; a citrate line also leading to an arterial blood line or a removal line; and a calcium line leading to a venous blood line or a return line.

[0087] Figure 3An exemplary embodiment of a disposable tubing set 4000 is shown, the disposable tubing set being arranged in a user-friendly and confusion-free manner on an organizer or tray. The organizer or tray is, for example, made of thermoformed plastic film and has an opening or channel in the pump area, wherein the opening simultaneously forms two eyelets 1501a and 1501b, and is configured to suspend and align the disposable tubing set 4000 onto two hooks or pins 1500a and 1500b at the front of the blood processing device 1000, as shown. Figure 2 As shown.

[0088] Figure 3 The disposable tubing assembly 4000 in the illustrated embodiment includes a blood line, removal line, or arterial line 1260 with a blood line pump segment 1262, and a return line or venous line 1270 with a bubble separator or venous chamber 1284. Additionally, a dialysis fluid pump segment 1221, a replacement fluid pump segment 1231, and a filtrate pump segment 1241 are also shown. Pump segments 1262, 1221, 1231, and 1241 are positioned and secured on a organizer or tray such that when the organizer or tray is suspended on two hooks or pins 1500a and 1500b at the front of the blood processing device 1000, they are aligned and correspond in a user-friendly and confusion-free manner in front of each roller pump (see [link to relevant documentation]). Figure 2 Furthermore, it can be functionally connected to the corresponding predetermined roller pump by the user in a way that avoids confusion, or it can be inserted into it for functional connection.

[0089] The dialysate line has a dialysate heating bag 1283, and the replacement fluid line has a replacement fluid heating bag 1281.

[0090] Figure 4 Showing from Figure 2 Details of an infusion pole 1700 with a hook 1701 on a blood processing device 1000, on which a liquid container 1800, in the present example a solution bag 1800, is suspended, filled with pre-filled liquid 1801. The pre-filled liquid forms a level 1802 due to gravity. The pre-filled liquid may, for example, be a sterile physiological NaCl solution. Figure 4 The arrow with the letter "g" in the middle indicates the direction of Earth's gravity.

[0091] like Figure 4 Combination Figure 2 As shown, if the user is in front of the blood processing device 1000 and sees... Figure 4The liquid container 1800 shown allows the user to see and monitor the level of the pre-filled liquid (1802) because at least a portion of the container is transparent. In this example, it is a solution bag made of plastic film, which is transparent in at least certain sections. The solution bag 1800 has an outlet connection 1810, which in this example is a short tube section with a connector 1820. The connector 1820 can be designed as a half of a Luer lock connector. In this example, the connector half 1820 connects to an optional transfer line 1830, which has a corresponding complementary connector half and an optional stopcock valve 1840. The optional stopcock valve 1840 connects to a... Figure 3 The disposable tubing assembly 4000 arterial patient connector 1261a. Figure 4 In the middle, the liquid container 1800 is connected in the manner shown according to... Figure 3 The arterial patient connector 1261a of the disposable tubing set 4000 allows pre-filled fluid to flow into the removal line 1260 (also known as the arterial line 1260) of the disposable tubing set 4000, at least under gravity, after the user manually opens the stopcock valve. Figure 3 4000 disposable tubing units Figure 4 The image is only schematically shown in the form of the arterial patient connector 1261a removed from the tubing, and is indicated by hand-drawn lines as if it were truncated. Therefore, Figure 4 It shows in Figure 2 The blood processing device 1000 has a liquid container 1800 ready for pre-filling on its infusion pole 1700.

[0092] Figure 5 The image shows a device in the pre-charge process according to the invention. Figure 2 A schematic diagram of the upper section of a blood processing device 1000, the blood processing device having a display screen 1100 with a touch screen 1110 and as shown in the diagram. Figure 4 The liquid container 1800 is shown located on the infusion pole 1700. Figure 5 In the middle, the upper section of the blood processing device 1000 shown is again shown as being cut off at the bottom with a hand-drawn line. Figure 5 The control and regulation device 1600 of the blood processing device 1000 is also schematically shown in dashed lines.

[0093] A first input button 1130, a second input button 1140, and an optional third input button 1150 are shown in the schematic diagram of the touchscreen 1110. The second input button 1140 and the optional third input button 1150 are shown in dashed lines to indicate that these input buttons do not necessarily need to be displayed simultaneously with the first input button 1130 in every display state of the touchscreen.

[0094] In some embodiments, the touchscreen has a first display state in which only the first input button 1130 is initially displayed. In a second display state, which follows the first display state sequentially, the touchscreen may additionally display a second input button 1140 and an optional third input button, or only display the second input button 1140. In the second display state, the first input button 1130 may optionally be completely hidden, or optionally displayed only in gray and without function. The precise positions of the first input button 1130, the second input button 1140, and the optional third input button 1150 on the touchscreen 1110 can be ergonomically determined. In some embodiments, in the second display state, the second input button 1140 may be displayed at the location of the first input button 1130 from the first display state and replace the first input button 1130.

[0095] Figure 5 With the above Figure 2 Similarly, the control and regulation device 1600 of the blood processing device 1000, schematically shown in dashed lines, is also illustrated.

[0096] Figure 6 A flowchart of an embodiment of the method according to the present invention is shown. Figure 6 This illustration shows which method steps the control and regulation device performs in an exemplary embodiment of the method according to the invention. A first method step includes displaying a user interface G1 on a touchscreen of a blood processing device for in vitro blood processing. A graphical output interface for text is displayed, having user-facing text T1 and a first input button E1. In an exemplary embodiment, the text T1 is, for example: "The pre-filled liquid container has been connected to the extracorporeal blood tubing system via liquid conduction." Initiate automatic delivery of pre-filled liquid? Optionally, a third input button E3 is shown, which can be used to alternatively abort the precharge or discard the incomplete precharge.

[0097] Alternatively, a timeout routine can be run in the control and regulation device during the display of the user interface G1. A time-limited clock can be run, and precharging can be automatically and completely stopped when the time limit is first reached or exceeded, and the control and regulation device does not detect actuation of the first input button E1 or the third input button E3 within the time limit.

[0098] When the user actuates the first input button E1, the control and regulation device executes the automatic "first step" P1. The control and regulation device actuates the blood pump, which delivers pre-filled fluid into the extracorporeal blood tubing at a specified target delivery rate. The control and regulation device progressively determines and stores the cumulative volume of the delivered pre-filled fluid, and stops the blood pump when the determined cumulative volume of the delivered pre-filled fluid first reaches or exceeds a specified first limit. Thus, the automatic pre-filling "first step" P1 is completed. Residual pre-filled fluid is intentionally retained in the fluid container, in this example, at 5%.

[0099] The user interface G2 is then displayed on the touchscreen. It displays a graphical output interface for text, which includes a user-facing text T2 and a second input button E2. In an exemplary embodiment, the text T2 is, for example: "Continue to manually pump the pre-filled liquid to completely empty the liquid container?" If the user actuates the second input button E2, the control and regulation device proceeds to "Second Step" P2. The control and regulation device actuates the blood pump, which delivers pre-filled fluid into the extracorporeal blood tubing at a specified target delivery rate. Here, the user manually determines how long the blood pump delivers. In an exemplary embodiment, for example, the blood pump delivers as long as the user holds the second input button E2 actuated, and stops when the user no longer holds the second input button E2 actuated. By re-acting the second input button E2, the blood pump can be restarted and pre-filled fluid delivered again. The user decides whether to stop the blood pump or not restart it when the fluid container becomes noticeably empty or once the fluid container becomes noticeably empty. To this end, the user observes the drop in the fluid level in the pre-filled fluid container during "Second Step" P2, where the pre-filled fluid container is suspended from the infusion pole of the blood processing device and is clearly visible to the user, such as... Figure 5 As shown.

[0100] Optionally, a third input button E3 can be alternatively displayed on the user interface G2. This third input button can be used to completely stop pre-filling or switch to the user interface G3. In other words, by actuating input button E3 on the user interface G2, the user can refuse or skip the offered function of manually continuing pre-filled liquid delivery, and the liquid container will not be completely emptied. In the exemplary embodiment, the query situation is differentiated when input button E3 is actuated because, for example, a situation may occur where the liquid container is empty, but pre-filling needs to be done again using another new liquid bag. For example, by briefly pressing input button E3, the user can refuse or skip the manual continuation of pre-filled liquid delivery and directly invoke user interface G3, or by actuating input button E3 for a longer time (e.g., longer than 3 seconds), pre-filling can be completely stopped. For this purpose, an indicative prompt can be displayed as text T2 or within text T2. When the manual continuation of pre-filled liquid delivery is refused or skipped, user interface G3 is displayed immediately.

[0101] Optionally, the manual pre-filling in step P2 can be automatically stopped by a control and regulation device when a stop criterion is reached, for example, when a second limit value for the pre-filled liquid volume to be delivered is reached. Therefore, uncontrolled and unattended manual continuation of delivery using a blood pump, especially manual continuation far exceeding the emptying range of the liquid container, can be prevented. This allows for a reasonableness check of "step two" P2 and automatic termination if necessary.

[0102] Alternatively, a timeout routine can be run in the control and regulation device during the display of user interface G2. During the display of user interface G2, a time-limited clock can be run in the control and regulation device, and precharging can be completely aborted if the time limit is reached or exceeded for the first time, and the control and regulation device does not detect actuation of the second input button E2 or the third input button E3 within the time limit. The clock can be displayed on user interface G2. The user can thus see how much time remains to confirm one of the input buttons before precharging is automatically and completely aborted. The timeout routine prevents the control and regulation device from remaining permanently on the display of user interface G2 (e.g., if the user never actuates any input button, such as if the user unexpectedly has to switch to another task with a higher priority).

[0103] A timeout routine with a clock can be set alternatively or additionally on optional user interfaces G1 and / or G3, and Figure 6 The timer symbols are shown in user interfaces G1, G2, and G3 respectively.

[0104] After the second step P2 or after briefly activating the input button E3 of the user interface G2, the user interface G3 is displayed on the touchscreen. A graphical output interface for text is displayed thereon, having a user-facing text T4 and a fourth input button E4. In an exemplary embodiment, the text T4 is, for example: "Should we continue prefilling using prefilled liquid from a new liquid container?" "A new liquid container with pre-filled liquid has been connected to the extracorporeal blood tubing system via liquid conduction." If the user actuates the fourth input button E4 and thus answers "yes" to the two questions in text T4, the control and adjustment device will again execute the "first step" P1 of automatic pre-charging. In other words, in Figure 6 The flowchart jumps back to function P1.

[0105] Optionally, a third input button E3 is additionally displayed on the user interface G3, which can be used to completely stop precharging if the user does not intend to continue precharging thereafter.

[0106] exist Figure 6 The method according to the invention, as shown in the flowchart, can be repeatedly performed continuously.

[0107] Texts T1, T2, and T4 can be displayed sequentially, with the text of the previous user interface being overwritten when a new user interface is displayed. This also applies to input buttons E1, E2, E3, and E4.

[0108] The sequence consisting of steps P1, E2, P2, E4, and then P1 again can also be run repeatedly as a loop until a specified amount of pre-filled liquid from multiple liquid containers has been delivered into the extracorporeal blood tubing assembly. For example, one, two, three, or even more than three liquid containers can be used sequentially for pre-filling.

[0109] According to the present invention, the stated object of the invention is achieved through the described exemplary embodiments. However, the invention is not limited to these exemplary embodiments.

[0110] List of reference numerals 1000 Blood processing devices for extracorporeal blood processing 1100 display screen 1110 Touchscreen 1120 Graphical output interface for text and / or symbols 1130 First Input Button 1140 Second Input Button 1150 Third Input Button 1160 Fourth Input Button 1210 Blood Pump 1215 Heparin Pump 1220 Dialysis Fluid Pump 1221 dialysis fluid pump tubing section 1230 Displacement Fluid Pump 1231 Displacement fluid pump piping section 1240 Filtrate pump, drain pump, dialysate pump 1241 Filtrate pump tubing section 1250 Blood processing module, dialyzer, blood filter 1251 Semi-permeable membrane Blood Room 1252 1253 Dialysis fluid chamber, filtrate chamber 1260 Blood lines, removal lines, arterial lines 1261 Remove clip or arterial clip 1261a Artery Patient Connector 1262 Blood line pump section 1270 Return line, intravenous line 1271 Return clip, vein clip 1271a Intravenous Patient Connector 1280 Replacement Fluid Container 1281 Displacement Fluid Heating Bag 1282 Dialysis fluid container 1283 Dialysis fluid heating bag 1284 Bubble Separator, Vein Chamber 1285 Filtrate container, drain container, dialysate container 1286 Heparin container 1290 Pressure gauge upstream of the blood pump 1291 Pressure measurement point downstream of the blood pump 1292 Pressure gauge for return pressure and venous pressure 1295 Optical Blood Leak Detector 1300 tube group receiving device 1500 a, 1500 b Hooks and pins 1600 Control and Regulation Device 1700 Suspension device, infusion rod 1701 Hook of the IV pole 1800 Liquid containers, solution bags 1801 Pre-filled liquid 1802 Pre-filled liquid level 1810 Outlet connection for liquid containers 1820 Connector for the outlet connection of a liquid container 1830 Transfer Pipeline 1840 Transfer line plug valve 3000 medical pipelines 3100 section 4000 disposable tubing sets g represents Earth's gravity, with the arrow pointing in the direction of Earth's gravity.

Claims

1. A medical blood processing device (1000) for performing extracorporeal blood processing using an extracorporeal blood tubing assembly having a blood processing module, comprising: At least one device for suspending at least one liquid container (1800), said at least one liquid container being filled with a pre-filled liquid of a specified initial volume. At least one blood pump (1210) having a rotor and a motor driver, the at least one blood pump being configured to functionally connect a tubing section of the extracorporeal blood tubing assembly, particularly a pump section (1262), wherein the blood pump (1210) has means for recording the number of revolutions and / or the rotation angle of the rotor. Control and regulation device (1600) with memory. A display screen (1100) has a touchscreen (1110) signal-connected to the control and regulation device (1600), wherein the control and regulation device (1600) is programmed to display a graphical output interface for text and / or visual representation on the touchscreen (1110), as well as at least one first input button (1130) and a second input button (1140), the at least one first input button being used to initiate the automatic delivery of the pre-filled fluid by means of the blood pump (1210). The control and regulation device (1600) is signal-connected to the motor driver to actuate the motor driver using an actuation voltage during the operation of the blood pump (1210), and is signal-connected to a device for recording the number of revolutions and / or rotation angle of the rotor. It is programmed to control and / or regulate the blood pump (1210) at a specified target delivery rate to deliver pre-filled fluid into the extracorporeal blood tubing assembly. Furthermore, the control and regulation device (1600) is programmed to progressively determine and store the cumulative volume of the pre-filled fluid being delivered based on (i) the operating time of the blood pump, (ii) the number of revolutions performed by the rotor, (iii) the angle of rotation performed by the rotor, or (iv) the actuation voltage of the motor driver. Capable of storing a specified initial volume of pre-filled liquid in the liquid container (1800). Its features are, The control and regulation device (1600) is additionally programmed to store in the memory a specified first limit value for a first portion volume of the pre-filled liquid, the first limit value being less than the initial volume of the pre-filled liquid in the liquid container (1800), and to actuate the blood pump (1210) to automatically deliver the pre-filled liquid at a specified target delivery rate if an actuation of the first input button (1130) is detected. If the determined cumulative volume of the pre-filled liquid being delivered first reaches or exceeds a specified first limit, the automatic delivery of the pre-filled liquid is stopped, and at least a second input button (1140) is displayed on the touchscreen (1110). A user prompt is also displayed on the graphical output interface via text and / or visual representation, indicating that the delivery of the pre-filled liquid can be manually continued by actuating the second input button. If an actuation of the second input button (1140) is detected, the delivery of the pre-filled liquid is restarted by means of the blood pump (1210).

2. The medical blood processing device according to claim 1, characterized in that, The control and regulation device (1600) is additionally programmed to automatically and completely terminate the precharge when no actuation of the second input button (1140) is detected within a specified time limit.

3. The medical blood processing device according to claim 1 or 2, characterized in that, The control and regulation device (1600) is additionally programmed to, If the automatic delivery of the pre-filled liquid stops, a third input button (1150) can be additionally displayed on the touchscreen (1110), and a user prompt can be additionally displayed on the graphical output interface via text and / or visual representation, indicating that by activating the third input button (1150) (i) pre-filling can be completely terminated, or (ii) by activating the third input button (1150) manual continuation of the pre-filled liquid can be refused, skipped, or terminated. Furthermore, if an actuation of the third input button (1150) is detected, the pre-charging can be (i) completely terminated or (ii) the manual continuation of the pre-charged liquid can be refused, skipped, or ended, and / or the pre-charging can be automatically terminated if no actuation of the third input button (1150) is detected within a specified time limit.

4. The medical blood processing device according to any one of claims 2 to 3, characterized in that, The control and adjustment device (1600) is additionally programmed to display a fourth input button (1160) on the touchscreen (1110) and to additionally display user prompts on the graphical output interface via text and / or visual representations, indicating that actuating the fourth input button (1160) can initiate the delivery of pre-filled liquid from another liquid container (1800), the other liquid container being filled with a specified initial volume of pre-filled liquid. Furthermore, if an actuation of the fourth input button (1160) is detected, the blood pump (1210) is actuated to start the delivery of pre-filled liquid from the other liquid container (1800).

5. The medical blood processing device according to any one of claims 1 to 4, characterized in that, The control and regulation device (1600) is programmed such that the first limit stored in the memory is 1% to 10% smaller than the initial volume of the pre-filled liquid in the liquid container (1800), preferably 3% to 7%, and particularly preferably 4% to 6%.

6. The medical blood processing device according to any one of claims 1 to 5, characterized in that, The control and regulation device (1600) is additionally programmed to continue the delivery of the pre-filled liquid as long as continuous actuation of the second input button (1140) is detected after actuation of the second input button (1140) is detected, and to stop the delivery of the pre-filled liquid when the second input button (1140) is no longer actuated.

7. The medical blood processing device according to any one of claims 1 to 5, characterized in that, The control and regulation device (1600) is additionally programmed to continue the delivery of the pre-filled liquid for a predetermined interval after detecting actuation of the second input button (1140), and to always resume the delivery of the pre-filled liquid at the predetermined interval when a re-application of the second input button (1140) is detected. The predetermined interval is defined by a termination criterion selected from the following group: (i) a specified rotor speed n=1 to 10 or a specified rotation angle, or (ii) a specified delivery volume from a numerical range V=1 ml to 50 ml, or (iii) a specified time interval from a numerical range t=1 second to 10 seconds.

8. The medical blood processing device according to any one of claims 1 to 7, characterized in that, The control and regulation device (1600) is additionally programmed to store a specified second limit for the maximum permissible volume of the total volume of the pre-filled liquid to be delivered, and to automatically and completely terminate the pre-filling process once the volume of the pre-filled liquid delivered first reaches or exceeds the specified second limit.

9. A method for pre-filling an extracorporeal blood tubing assembly on a blood processing device (1000) for extracorporeal blood processing, comprising the following steps: A medical blood processing device (1000) according to any one of claims 1 to 8, at least one liquid container (1800), and an extracorporeal blood tubing assembly having a blood processing module (1250) are provided, wherein the at least one liquid container is filled with a pre-filled liquid of a specified initial volume. The user suspends the at least one liquid container (1800) containing pre-filled liquid onto at least one device (1700) for suspension, particularly onto the infusion pole (1700). The user functionally connects the tubing sections of the extracorporeal blood tubing assembly, particularly the pump tubing section (1262), to the blood pump (1210). The user connects the liquid container (1800) to the tubing of the extracorporeal blood tubing assembly for liquid connection. The control and adjustment device (1600) displays a graphical output interface for text and / or visual representation and at least one first input button (1130) on the touch screen (1110), the at least one first input button being used to initiate the automatic delivery of the pre-filled fluid by means of the blood pump (1210). The control and regulation device (1600) detects actuation of the first input button (1130) and subsequently actuates the blood pump (1210) to cause automatic delivery of the pre-filled liquid by means of the blood pump (1210). When the determined volume of the pre-filled liquid being delivered first reaches or exceeds a specified first limit, the automatic delivery of the pre-filled liquid is stopped by the control and regulation device (1600). Furthermore, at least one second input button (1140) is displayed on the touchscreen (1110), and a user prompt is displayed on the graphical output interface, indicating that by activating the second input button (1140), the delivery of the pre-filled fluid by means of the blood pump (1210) can be continued manually. If an actuation of the second input button (1140) is detected, the delivery of the pre-filled liquid by means of the blood pump (1210) is restarted by the control and regulation device (1600).

10. The method for pre-charging according to claim 9, characterized in that, The method includes the following additional steps: When no actuation of the second input button (1140) is detected within the specified time limit, the precharge is automatically and completely terminated by the control and regulation device (1600).

11. The method for pre-charging according to any one of claims 9 to 10, characterized in that, The method includes the following additional steps of the control and regulation device (1600): After the automatic delivery of the pre-filled liquid stops, a third input button (1150) is additionally displayed on the touch screen (1110), and a user prompt is additionally displayed on the graphical output interface, indicating that by activating the third input button (1150) (i) the pre-filling can be completely terminated, or (ii) the manual continuation of the pre-filled liquid can be refused, skipped, or ended by activating the third input button (1150). Furthermore, if actuation of the third input button (1150) is detected, then (i) pre-charging is terminated completely, or (ii) manual continuation of the pre-charged liquid is rejected, skipped, or terminated. And / or if no actuation of the third input button (1150) is detected within the specified time limit, the precharge is automatically and completely terminated.

12. The method for pre-charging according to any one of claims 9 to 11, characterized in that, The method includes the following additional steps of the control and regulation device (1600): The delivery of the pre-filled liquid continues as long as continuous actuation of the second input button (1140) is detected, and When it is detected that the second input button (1140) is no longer actuated, the delivery of the pre-filled liquid is stopped.

13. The method for pre-charging according to any one of claims 9 to 11, characterized in that, The method includes the following additional steps of the control and regulation device (1600): If an actuation of the second input button (1140) is detected, the delivery of the pre-filled liquid continues for a predetermined interval, and if a re-application of the second input button (1140) is detected, the delivery of the pre-filled liquid continues again at predetermined intervals, wherein the predetermined intervals are defined by a stop criterion selected from the group consisting of: (i) a specified rotor speed n = 1 to 10 or a specified rotation angle, or (ii) a specified delivery volume from a numerical range V = 1 ml to 50 ml, or (iii) a specified time interval from a numerical range t = 1 second to 10 seconds.

14. The method for pre-charging according to any one of claims 9 to 13, characterized in that, The method includes the following additional steps of the control and regulation device (1600): Pre-charging is automatically and completely terminated once the volume of the pre-charged liquid reaches or exceeds the specified second limit for the first time.