Medical blood treatment apparatus for extracorporeal blood treatment, and method for priming an extracorporeal blood tube set on the blood treatment apparatus
The medical blood treatment device addresses the issues of air entry and inefficiencies in priming extracorporeal blood tubing sets by implementing an automatic partial emptying process and user-guided complete emptying, enhancing safety and reducing environmental and cost burdens.
Patent Information
- Application Number
- PCT/EP2024/085843
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2023-12-15
- Filing Date
- 2024-12-12
- Publication Date
- 2025-06-19
AI Technical Summary
Existing methods for priming extracorporeal blood tubing sets during medical treatments often result in unnoticed air entry and inefficiencies, such as excessive use of priming fluid and containers, leading to environmental and cost issues.
A medical blood treatment device with a control and regulation system that performs an automatic partial emptying of the priming fluid container, ensuring only 95% of the fluid is pumped into the tubing set, thereby preventing air ingress, and allows for user-guided complete emptying of the container to minimize waste.
The solution effectively prevents air entry into the extracorporeal blood tubing set during priming, optimizes the use of priming fluid and containers, reducing environmental impact and costs, while ensuring patient safety and efficient treatment preparation.
Smart Images

Figure EP2024085843_19062025_PF_FP_ABST
Abstract
Description
[0001] Medical blood treatment device for extracorporeal blood treatment and method for priming an extracorporeal blood tubing set on the blood treatment device
[0002] Technical area
[0003] The invention relates to the filling of a blood tubing line on a blood treatment device for extracorporeal blood treatment with a priming fluid from a fluid container as a preparatory step before starting an extracorporeal blood treatment.
[0004] background
[0005] Various methods for priming an extracorporeal blood line are known. One of the priming methods, known from the multiFiltratePRO blood treatment device from the applicant Fresenius Medical Care Deutschland GmbH, among others, involves connecting a fluid container containing priming fluid to the arterial patient connector of the disposable extracorporeal blood line, and connecting an empty waste bag to the venous patient connector of the extracorporeal blood line. Using the blood pump, priming fluid is pumped from the fluid container through the extracorporeal blood line, including the blood treatment module, and into the waste bag. This process expels air from the extracorporeal blood line, and flushes out any residues from manufacturing and sterilization.
[0006] A disposable tubing line is a tubing system or line configured as a single-use or disposable item that is disposed of or discarded after a single use. In special blood treatment devices for continuous extracorporeal blood treatment (abbreviated to "CKRT" for Continuous Kidney Replacement Therapy) or blood treatment devices for acute extracorporeal blood treatment in intensive care medicine or intensive care units (abbreviated to "ICU" for "intensive care unit"), the dialysate line or filtrate line, like the extracorporeal blood circuit, are also designed as disposable tubing lines, and the required medical solutions such as dialysis fluid and substitution fluid or substituate, as well as the priming fluid, are provided as ready-made solutions in solution bags.Such disposable tubing lines, such as the extracorporeal blood tubing line, are connected by the user from the outside to the functional interfaces of the blood treatment device before performing an extracorporeal blood treatment. Among other things, a tubing section of the extracorporeal blood tubing line, in particular a pump tubing segment, is inserted into a tubing receiving area of a blood pump arranged on the outer surface of the blood treatment device and accessible from the outside. Summary of the invention.
[0007] An object of the present invention is to prevent unnoticed air entry into an extracorporeal blood tubing set during priming.
[0008] A further object of the present invention is to enable the user to prime the extracorporeal blood tubing set with priming fluid from a fluid container while completely emptying this fluid container, while at the same time avoiding unnoticed air ingress into the extracorporeal blood tubing set.
[0009] A further objective is to propose a further method and device for priming an extracorporeal blood tubing set, which can be implemented simply through a software update in the control system of the extracorporeal blood treatment device. For example, a conceivable weighing device for more precise measurement of the current fluid volume in the fluid container or a similarly conceivable level measurement on the fluid container using sensors can be eliminated for cost reasons, while simultaneously improving patient safety.
[0010] Another goal is to avoid the need to discard excessive amounts of unused priming fluid. This will achieve environmental benefits and cost savings.
[0011] Another objective is to avoid the consumption of an excessive number of priming fluid containers compared to the volume of priming fluid actually required for priming. This is intended to achieve ecological benefits and cost savings. Another objective is to avoid the time required for attaching and connecting an excessive number of priming fluid containers by only attaching and connecting a minimum number of priming fluid containers corresponding to the required amount of priming fluid.
[0012] The present invention relates to a blood treatment device for extracorporeal blood treatment having the features of claims 1 to 8 and a method for priming an extracorporeal blood tubing set having the features of claims 9 to 14.
[0013] The objects are achieved according to the invention with the features of independent claims 1 and 9. Advantageous embodiments are the subject of the subclaims. The advantages of the blood treatment device according to the invention according to claim 1 can be achieved without reduction with the method according to claim 9.
[0014] The method according to the invention for priming an extracorporeal blood tubing set begins with an automatic priming step, hereinafter referred to simply as the "first step," which is controlled by a control and regulation device using a computer program, in particular without any user intervention during priming. After the "first step," the method according to the invention comprises steps to be performed at least partially manually by the user, hereinafter referred to simply as the "second step."
[0015] The blood treatment device according to the invention comprises a machine housing and a, in particular electronic, control and regulating device for controlling and regulating the extracorporeal blood treatment.
[0016] The blood treatment device according to the invention has a screen user interface with a graphical user interface (GUI) embodied as a touchscreen. The touchscreen has a bidirectional signal connection with the control and regulation device, so that graphic and textual information can be displayed on the touchscreen and user inputs can be transmitted to the control and regulation device via input buttons, for example, confirmation buttons. The actuation of the input buttons can be or include manual actuation, for example, by tapping or pressing with a finger, for example, once or repeatedly, or by holding the tap or pressing.
[0017] The blood treatment device comprises at least one blood pump configured to pump blood through at least one blood tubing line to be connected for extracorporeal blood treatment. The connected blood tubing line can be part of a disposable tubing set. The control and regulation device is in signal communication with the blood pump.
[0018] The blood pump may be a peristaltic pump, in particular a peristaltic roller pump. The blood pump is then configured to accommodate a blood line pump tubing segment of the blood tubing line.
[0019] The blood pump has an electric drive motor, with a stator and rotor accessible to the user on the outside of the machine housing. The control and regulation device is in signal communication with the electric drive motor.
[0020] The control and regulation device has one or more CPUs (Central Processing Units) and a memory for storing a computer program. When running, the computer program executes the automatic steps of the priming method according to the invention and provides user guidance on the touchscreen for performing the manual steps and processes user inputs on the touchscreen that are required to perform the manual steps. The machine housing has at least one device for hanging at least one liquid container, in particular an infusion rod with at least one hook on which a liquid container filled with a predetermined initial volume of priming liquid can be hung.
[0021] The specified initial volume of the priming fluid in the fluid container to be used by the user is entered or selected as a parameter during setup via the Graphical User Interface (GUI). The input can be made by the user or it can be predefined in the control and regulation device. The value can vary depending on the process, for example, 1,000 ml, 2,000 ml, or 3,000 ml, and in particular, 1,000 ml.
[0022] The liquid container can, in particular, be a solution bag with at least one outlet. The solution bag consists, in particular, of a plastic film.
[0023] The blood tubing to be connected for extracorporeal blood treatment can be selected from the group: collection line, arterial line, return line, venous line.
[0024] Since the control and regulation device is suitable for running a computer program in its memory, no hardware changes to the blood treatment device are required to achieve the objects according to the invention, but only software changes.
[0025] Optionally, the machine housing has a base with four castors so that the machine housing can stand on the floor with its castors and be pushed by the user to another location or rotated around its vertical axis into an ergonomic working position.
[0026] According to the invention, an automatic partial emptying of the liquid container is proposed as a “first step”, wherein the automatic partial emptying is automatically stopped for safety reasons in good time before the liquid container is completely emptied, so that initially a residue of priming liquid, for example 5%, remains in the liquid container.
[0027] To carry out the method according to the invention, the standardized liquid containers with priming liquid known from the prior art are used, which are each sterilely prefilled with a predetermined volume of priming liquid, in particular physiological NaCl solution, for example with 1,000 ml of physiological NaCl solution.
[0028] When operating the blood pump, the actual flow rate in practice can, for example, deviate from the target flow rate by up to + / - 5%, whereby the actual flow rate depends on many influencing factors and is usually unknown and not measured, and deviations usually go unnoticed.
[0029] The blood pump of the blood treatment device according to the invention is controlled at a predetermined target flow rate such that only a portion of the priming fluid is automatically pumped from the fluid container into the extracorporeal blood tubing set, e.g., only 95%. For this purpose, the control and regulation device continuously determines the calculated volume of pumped priming fluid during the first step and stops the blood pump as soon as the pumped fluid volume reaches or exceeds a predetermined first limit for the first time.
[0030] For a given volume of 1,000 ml, for example, only 950 ml would be automatically pumped from the fluid container into the extracorporeal blood tubing set, leaving 50 ml left in the fluid container. A first limit value is set in the control and regulation device for the partial quantity of priming fluid to be automatically pumped. The first limit value is always less than the initial volume of priming fluid in the fluid container and can be determined, for example, as follows. The first limit value can, for example, be automatically calculated by the control system from the given initial volume of priming fluid and a given factor “f” that takes into account the expected inaccuracy of the pump, for example f = 0.95, i.e. 95% of the initial volume, i.e. the first limit value in this example is 950 ml.
[0031] If, for example, the blood pump were actually to pump at a higher delivery rate than the specified target delivery rate, then when pumping the priming fluid from a 1,000 ml bag, the blood pump would still continue to run after 1,000 ml had actually already been pumped from the bag, until the control and regulation device mathematically recognizes that 1,000 ml had been pumped in accordance with the specified target delivery rate.In such a case, the blood pump would drain the bag and part of the tubing, creating a significant negative pressure on its suction side and in the empty bag. This creates the risk of air from the environment entering unnoticed, for example through the arterial patient connector, for example if the arterial patient connector was inadvertently not screwed tightly enough to the connector of the fluid container, or due to other possible leaks. This is prevented by the "first step" according to the invention. If the blood pump would otherwise actually deliver at a lower flow rate than the specified target flow rate, a residue of priming fluid would remain in the bag anyway, which also fulfills the purpose of the first step.
[0032] The control and regulation device controls the blood pump in the “first step” in such a way that under no circumstances are so many revolutions carried out that the fluid container is automatically pumped completely empty, or even beyond that.
[0033] This first step, according to the invention, prevents the blood pump from sucking in air from the environment through leaks and pumping it into the extracorporeal bloodstream. Various calculation approaches can be used to determine the volume of pumped priming fluid, for example:
[0034] 1. In some embodiments, the control and regulation device can be configured to calculate the calculated volume of the pumped priming fluid during the "first step" by continuously integrating the predetermined target delivery rate of the blood pump over the running time of the blood pump. The target delivery rate can, for example, have the unit "ml per unit of time." Optionally, a characteristic curve or a characteristic map for the target delivery rate of the blood pump can be stored in the control and regulation device as a function of possible additional influencing variables, such as the properties of the pump tube segment or correction factors.
[0035] 2. In some other embodiments, the control and regulating device can be configured to calculate the calculated volume of the pumped priming fluid during the "first step" by continuously integrating the predetermined specific target delivery volume of the blood pump per rotor revolution over the measured number of revolutions of the rotor of the roller pump. For this purpose, the number of revolutions of the rotor of the roller pump is continuously measured using at least one magnet on the pump rotor and at least one Hall sensor on the pump stator and continuously evaluated in the control and regulating device. With two diagonally opposite magnets on the pump rotor and a Hall sensor on the pump stator, for example, full (360°) or half (180°) revolutions can be recorded and counted.The control and regulation device can optionally store a characteristic curve or a characteristic map for the specific target delivery volume of the blood pump per rotor revolution as a function of possible additional influencing variables, such as the properties of the pump tube segment or correction factors. The specific target delivery volume of the blood pump can, for example, have the unit "ml per revolution." In yet other embodiments, the control and regulation device can be configured to determine the calculated volume of the pumped priming fluid during the "first step" by continuously integrating the predetermined specific target delivery volume of the blood pump per rotation angle or per rotation angle step over the rotation angle of the rotor executed during the running time of the blood pump.For this purpose, a characteristic curve or a characteristic map for the relationship between the specific target delivery volume of the blood pump per rotation angle or per rotation angle step and possible other influencing variables, such as the properties of the pump tube segment or correction factors, can be stored in the control and regulating device. This embodiment is particularly advantageous if the electric drive motor of the blood pump is a stepper motor that can execute defined rotation angles or rotation angle steps. In some embodiments, the control and regulating device can be configured to determine the calculated volume of the delivered priming fluid during the "first step" by continuously detecting the control voltage of the electric drive motor of the blood pump, continuously calculating the delivery rate of the blood pump from this, and continuously integrating the calculated delivery rate of the blood pump over the running time of the blood pump.For this purpose, a characteristic curve or characteristic map for the relationship between the control voltage of the motor drive and the delivery rate, optionally depending on possible additional influencing variables such as the properties of the pump hose segment or correction factors, can be stored in the control and regulation device. 5. In yet other embodiments, the control and regulation device can be configured to combine two or more of the aforementioned methods to calculate the calculated volume of the delivered priming fluid during the "first step." For example, this can be used to check plausibility and increase reliability.
[0036] If more than one standardised fluid container is required for the priming process in preparation for certain treatment procedures, for example because a priming volume of 2,000 ml is prescribed depending on the procedure, repeating this first step with new fluid bags each containing 1,000 ml of priming fluid would result in, for example, 5% unused residue remaining in the first fluid container and another 5% unused residue remaining in the next fluid container used containing 1,000 ml of priming fluid, so that 10% is still missing until the prescribed priming volume of 2,000 ml is reached, so that even a third fluid container is needed to achieve the prescribed priming volume of 2,000 ml, in which even 90% unused residue would remain.
[0037] The "first step" alone therefore entails the disadvantage that, without the "second step" of the inventive method, incompletely emptied liquid containers must be disposed of. Therefore, according to the invention, at least the "second step" is provided for completely emptying the remaining priming liquid from the liquid containers, whereby the "second step" can be started manually by the user. The user can see how far the liquid container has been emptied after the "first step."
[0038] The liquid container is therefore preferably a flexible liquid bag, for example, one of the well-known NaCl solution bags. The liquid container is preferably transparent at least in sections so that the user can see the liquid level within it. The tube is also transparent. According to the invention, the "second step" for manually emptying the remaining priming liquid from the liquid container is carried out with user guidance provided by the control system of the blood treatment device via the screen user interface of the blood treatment device, in particular via a touchscreen of the blood treatment device.For this purpose, the blood treatment device's control system displays a text message on the touchscreen, informing the user that the liquid container with priming fluid can optionally be completely emptied in a user-guided manner after completion of the automatic partial emptying. According to the invention, the blood treatment device's control system provides at least one input button on the touchscreen, in particular a confirmation button with a "user-guided residual emptying" button and an optional "no user-guided residual emptying, discard residual fluid" button, via which the user can execute or reject the user-guided residual emptying option.The user-guided residual emptying requires the user's attention for a short time because the user must monitor the falling liquid level of the priming liquid during the user-guided residual emptying and must abort the user-guided residual emptying as soon as the liquid container is completely empty, in particular by manually entering a command on the touchscreen to stop the blood pump as soon as it is visually apparent that the liquid container is completely empty or that the liquid level of the priming liquid has reached a height in the tubing section below the outlet opening. In particular, the user can enter the command to stop the conveying device, in particular the blood pump, on the touchscreen when they see that the liquid level of the priming liquid has reached a height in the outlet connection of the liquid container or the transfer tubing.
[0039] If the user does not have time for user-guided residual emptying, they can reject the option by pressing the optional "no user-guided residual emptying" button, accepting the disadvantages described. In intensive care units in particular, the user's attention is often required simultaneously for several prioritized tasks. One of many possible examples is when, while a blood treatment device is being set up for a planned blood treatment, blood treatments on other blood treatment devices in the same room simultaneously lead to alarms requiring action, and the user must prioritize the tasks according to importance. The optional "no user-guided residual emptying" button therefore prevents the user's attention from being overly tied up in critical situations.
[0040] The target flow rate of the blood pump can optionally be set lower for the “second step” than for the “first step”, so that visual monitoring of the priming fluid level in the “second step” is particularly user-friendly and the command to stop the blood pump can be entered by the user in a timely manner.
[0041] The control and regulation device can provide a predefined termination criterion for the "second step," in particular a second limit for the pumped volume of priming fluid. When 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 any user intervention. This prevents the user from mistakenly allowing the blood pump to continue running even though the fluid container is already clearly empty.
[0042] The medical blood treatment device for extracorporeal blood treatment using an extracorporeal blood tubing set with a blood treatment module comprises at least one device for suspending at least one liquid container filled with a predetermined initial volume of priming fluid, and comprises at least one blood pump with a rotor and a motor drive, which is configured for functionally coupling a line section of the extracorporeal blood tubing set, in particular a pump tubing segment. The blood pump comprises a device for detecting the number of revolutions and / or the angle of rotation of the rotor. Examples of a blood treatment module are a dialyzer, a hemofilter, a hemodiafilter, a membrane gas exchanger, and an adsorber.
[0043] The medical blood treatment device comprises a control and regulating device with a memory and a screen with a touchscreen in signal connection with the control and regulating device, wherein the control and regulating device is programmed to display on the touchscreen a graphic output area for text and / or image representation and at least one first input button for starting the automatic delivery of the priming fluid by means of the blood pump and a second input button, and wherein the control and regulating device is connected in signal connection to the motor drive for controlling the motor drive with a control voltage during a running time of the blood pump and is connected in signal connection to the device for detecting the number of revolutions and / or the angle of rotation of the rotor,and is programmed to control and / or regulate the blood pump at a predetermined target delivery rate for delivering the priming fluid in the extracorporeal blood tubing set, and wherein the control and regulation device is programmed to continuously determine and store the amount of the integral volume of the delivered priming fluid based on (i) the running time of the blood pump or (ii) the number of revolutions of the rotor or (iii) the angle of rotation of the rotor or (iv) the control voltage of the motor drive, and to store the predetermined amount of the initial volume of the priming fluid of the fluid container.
[0044] The control and regulation device is additionally programmed such that a predetermined first limit value for a first partial volume of the priming fluid is stored in the memory, which is smaller than the amount of the initial volume of the priming fluid in the fluid container, and when an actuation of the first input button is detected, the blood pump is controlled to automatically deliver the priming fluid at the predetermined target delivery rate and, when the determined integral volume of the delivered priming fluid has reached the predetermined first limit value or exceeds it for the first time, the automatic delivery of the priming fluid is stopped and at least the second input button is displayed on the touchscreen and a user message is displayed on the graphic output surface by means of text and / or image representation,that by pressing the second input button, the pumping of the priming fluid can be continued manually, and when an actuation of the second input button is detected, the pumping of the priming fluid is restarted by means of the blood pump.
[0045] When the first input button is detected, this is considered user confirmation that the priming fluid container is connected to the extracorporeal blood tubing set and that the priming fluid delivery can be started using the blood pump. A user message on the graphical output surface can alert the user of this.
[0046] In some embodiments, the medical blood treatment device is further characterized in that the control and regulation device is additionally programmed to automatically terminate the priming if no actuation of the second input button is detected within a predetermined time limit.
[0047] In some embodiments, the medical blood treatment device is additionally characterized in that the control and regulating device is additionally programmed, when the automatic delivery of the priming fluid is stopped, to additionally display a third input button on the touchscreen and to additionally display a user notification on the graphic output surface by means of text and / or image representation that by pressing the third input button (i) the priming can be finally ended, or that (ii) by pressing the third input button a manual continuation of the delivery of the priming fluid can be rejected, skipped or ended and, if an actuation of the third input button is detected, (i) to finally end the priming or (ii) to reject, skip or end a manual continuation of the delivery of the priming fluid.This advantageously makes it possible to (ii) immediately and conclusively terminate priming or (ii) immediately reject, skip, or terminate a manual continuation of the delivery of the priming fluid. Optionally, the control and regulation device can also be programmed to automatically and conclusively terminate priming if no actuation of the third input button is detected within a predefined time limit. This advantageously makes it possible to terminate priming in a defined manner if no actuation of the third input button is detected, particularly if the user ignores the third input button.
[0048] Depending on the treatment procedure to be performed and the extracorporeal blood line set and / or blood treatment module required, a different amount of priming fluid may be required, which may, for example, require more than one fluid container with priming fluid.In some embodiments, the medical blood treatment device is additionally characterized in that the control and regulating device is additionally programmed to display a fourth input button on the touchscreen and to additionally display a user instruction on the graphic output area by means of text and / or image representation that by actuating the fourth input button the delivery of priming fluid from a further fluid container which is filled with the predetermined initial volume of priming fluid can be started and by actuating the fourth input button the blood pump is controlled to deliver the priming fluid at the predetermined target delivery rate.
[0049] Pressing the fourth input button is considered as confirmation by the user that the additional fluid container with priming fluid is fluid-conductingly connected to the extracorporeal blood tubing set.
[0050] The fourth input button may be displayed in particular when the automatic delivery of the priming fluid has been stopped and / or when a manual continuation of the delivery of the priming fluid has been rejected, skipped or terminated.
[0051] According to the invention, the control and regulation device is programmed such that the first limit value stored in the memory is 1% to 10%, preferably 3% to 7%, particularly preferably 4% to 6% smaller than the initial volume of the priming liquid in the liquid container. This maintains a sufficiently large safety margin from the initial volume of the priming liquid in the liquid container and prevents an uncontrolled automatic continuation of the delivery of priming liquid from the liquid container and the ingress of air.
[0052] By way of example, different algorithms for pumping priming fluid upon actuation of the second input button are disclosed, which are particularly user-friendly and therefore advantageous.
[0053] In some embodiments, the medical blood treatment device is additionally characterized in that the control and regulating device is additionally programmed, after detecting an actuation of the second input button, to continue the delivery of the priming fluid as long as continuous actuation of the second input button is detected, and to stop the delivery of the priming fluid when it is detected that the second input button is no longer being actuated. While monitoring the fluid level in the fluid container, the user can keep the second input button pressed for as long as they wish to deliver priming fluid. Releasing the second input button immediately stops the delivery of the priming fluid.This is advantageous because the user does not have to look away from the fluid level in the fluid reservoir and can stop the priming fluid flow very quickly when the fluid reservoir is clearly empty. This advantageously prevents the user from manually dispensing the priming fluid for too long.In other embodiments, the medical blood treatment device is characterized in that the control and regulating device is additionally programmed to continue the delivery of the priming liquid at a predetermined interval after detecting an actuation of the second input button, and to always continue the delivery of the priming liquid again at the predetermined interval if a renewed actuation of the second input button is detected, wherein the predetermined interval is limited by a termination criterion selected from the group (i) a predetermined number of rotor revolutions n = 1 to 10 or a predetermined angle of rotation or (ii) a predetermined delivery volume from the value range V = 1 ml to 50 ml or (iii) a predetermined time interval from the value range t = 1 s to 10 s.In other words, the user can pump the priming fluid in several small, automatic steps by repeatedly tapping the second input button. This allows the user to intuitively determine whether another interval is required until the fluid container is visibly empty. This advantageously prevents the user from manually pumping the priming fluid for too long.
[0054] A lower target delivery rate of the blood pump can optionally be specified during the predetermined interval, allowing the user to intuitively and easily determine whether another interval is required until the fluid container is visibly empty. In other words, the predetermined interval can correspond to the delivery of a bolus of priming fluid. The user can deliver or dose multiple boluses of priming fluid consecutively.
[0055] In some embodiments, the medical blood treatment device is additionally characterized in that the control and regulating device is additionally programmed to store a predetermined second limit value for the maximum permissible volume of the total priming fluid to be pumped, and to automatically terminate priming as soon as the volume of the pumped priming fluid has reached the predetermined second limit value or exceeds it for the first time. This advantageously automatically prevents the user from manually pumping the priming fluid for too long due to incorrect operation. The maximum permissible volume of the total priming fluid to be pumped can, for example, correspond to the sum of the initial volume of the priming fluid in the fluid container and a portion of the volume of the transfer tube line.
[0056] The blood treatment device according to the invention can be selected from the group: hemodialysis machine, hemofiltration machine, hemodiafiltration machine, acute dialysis machine, CRRT machine, CKRT machine, apheresis machine. The older abbreviation CRRT stands for "Continuous Renal Replacement Therapy" and the newer abbreviation CKRT stands for "Continuous Kidney Replacement Therapy."
[0057] Using the medical blood treatment device according to the invention, the user can perform the method according to the invention for priming an extracorporeal blood tubing set on the blood treatment device. The method according to the invention comprises the following steps.
[0058] The medical blood treatment device according to the invention, a liquid container filled with a predetermined initial volume of priming liquid, and an extracorporeal blood tubing set with a blood treatment module are provided.
[0059] The user hangs the at least one liquid container with priming fluid on the at least one hanging device, in particular on the infusion pole, and functionally couples a line section of the extracorporeal blood tubing set, in particular a pump tubing segment, to the blood pump. Functional coupling, for example, in the case of a roller pump, means that the pump tubing segment is inserted into the blood pump so that the blood pump can pump a liquid content in the pump tubing segment. Functional coupling occurs, for example, as part of the upgrading of the blood treatment device before the start of extracorporeal blood treatment.
[0060] The user connects the fluid container to a tubing line of the extracorporeal blood tubing set in a fluid-conducting manner.
[0061] The control and regulation device displays a graphical output area for text and / or image representation and at least one first input button on the touchscreen.
[0062] When the phrase "actuation of an input button is detected" is used in this disclosure, this always means that the control and regulation unit receives a signal from the touchscreen that the corresponding input button on the touchscreen has been touched or tapped. The touching or tapping is typically performed manually by the user, for example, with one of their fingers.
[0063] The control and regulating device detects an actuation of the first input button and then causes the conveying device, in particular the blood pump, to be activated in order to automatically convey priming fluid, and a stopping of the automatic conveying of the priming fluid when the determined volume of the conveyed priming fluid has reached a predetermined first limit value or exceeds it for the first time, and a display on the touchscreen of at least the second input button and the user instruction on the graphic output area that the conveying of the priming fluid can be continued manually by actuating the second input button, and a restart of the conveying of the priming fluid when an actuation of the second input button is detected.
[0064] When the first input button is detected, this is considered user confirmation that the fluid container with priming fluid is connected to the extracorporeal blood tubing set and that the delivery of the priming fluid can be started using the blood pump. The control and regulation device can display a user message on the graphical output surface and alert the user accordingly.
[0065] In some embodiments, the priming method comprises the additional step of automatically terminating the priming by the control and regulation device if no actuation of the second input button is detected within a predetermined time limit.
[0066] In some embodiments, the priming method comprises the additional steps of the control and regulation device that, after stopping the automatic delivery of the priming liquid, a third input button is additionally displayed on the touchscreen and a user message is additionally displayed on the graphical output area, that by pressing the third input button (i) priming can be finally ended or (ii) manual continuation of the delivery of the priming liquid can be rejected, skipped or ended by pressing the third input button and that, if an actuation of the third input button is detected, (i) priming is finally ended or (ii) manual continuation of the delivery of the priming liquid is rejected, skipped or ended, and / or that if no actuation of the third input button is detected within a predetermined time limit,the automatic priming is finally terminated.,
[0067] In some embodiments, the priming method comprises the additional steps of the control and regulation device of continuing the delivery of the priming liquid as long as a continuous actuation of the second input button is detected, and stopping the delivery of the priming liquid when it is detected that the second input button is no longer actuated.
[0068] In some other embodiments, the priming method comprises the additional steps of the control and regulating device in that the delivery of the priming liquid is continued at a predetermined interval when actuation of the second input button is detected, and in that the delivery of the priming liquid is always continued at the predetermined interval when renewed actuation of the second input button is detected. The predetermined interval is limited by a termination criterion selected from the group (i) a predetermined number of rotor revolutions n = 1 to 10 or a predetermined angle of rotation or (ii) a predetermined delivery volume from the value range V = 1 ml to 50 ml or (iii) a predetermined time interval from the value range t = 1 s to 10 s.
[0069] In some embodiments, the priming method comprises the additional step of the control and regulation device that the priming is automatically terminated as soon as the volume of the pumped priming liquid has reached or for the first time exceeds a predetermined second limit value.
[0070] Short description of the characters
[0071] Figure 1 shows a schematic representation of an extracorporeal blood circuit.
[0072] Figure 2 shows a view of an exemplary blood treatment device for extracorporeal blood treatment.
[0073] Figure 3 shows a schematic representation of an exemplary embodiment of a disposable tubing set for extracorporeal blood treatment.
[0074] Figure 4 shows a schematic representation of an exemplary embodiment of a liquid container with priming liquid, hanging on an infusion pole.
[0075] Figure 5 shows a schematic view of an upper section of the blood treatment device of Figure 2 during priming according to the invention.
[0076] Figure 6 shows a flowchart of an embodiment of the method according to the invention. Detailed description of an embodiment
[0077] An exemplary embodiment of the blood treatment device according to the invention is described in more detail below with reference to the figures. Further details and advantages of the invention are described in more detail with reference to the exemplary embodiment described in the figures. The reference numerals in the figures have the same meaning throughout. The method according to the invention can be carried out using the blood treatment device according to the invention.
[0078] Figure 1 shows a schematic representation of an extracorporeal blood circuit. The extracorporeal blood circuit has a withdrawal line or arterial blood line 1260 with a blood pump 1210, by means of which the blood is sucked from a patient's vascular access and directed into the blood chamber of a dialyzer or blood filter 1250. The blood is then directed from the blood chamber 1260 back into the patient's vascular access via a return line or venous line 1270 with an air bubble separator or a venous chamber 1284. The patient-side ends of the withdrawal line or arterial blood line 1260 and the return line or venous line 1270 have a withdrawal clamp or arterial clamp 1261 and a return clamp or venous clamp 1271, respectively, by means of which the flow can be interrupted by clamping the tubing by machine-side actuators.The patient-side end of the withdrawal 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. The patient connectors 1261a and 1271a are configured for connection to the complementary connector halves of a central venous catheter or an arterial and venous puncture cannula, with which access to the vascular system of a patient can be established. The patient connectors 1261a and / or 1271a can also be used to connect a fluid container containing priming fluid, with the outlet of the fluid container then having a matching complementary connector half.The dialyzer or blood filter 1250, chosen here as an example of a blood treatment module, is divided internally by a semipermeable membrane 1251 into a blood chamber and a dialysate chamber or filtrate chamber. In the case of hemodialysis, a dialysis fluid is supplied to the dialysate chamber by means of a dialysis fluid pump 1220 in a dialysis fluid line, which is provided in a dialysis fluid container 1282. The dialysis fluid can be heated in a dialysis fluid heating bag 1283 on its way to the dialysate chamber. During hemodialysis, substances to be separated from the blood diffuse through the semipermeable membrane into the dialysate chamber. The dialysate, loaded with the substances to be separated and to be discarded, is discharged into a dialysate container 1285 by means of a dialysate pump 1240 in a medical tubing line 3000.In the case of purely convective hemofiltration, filtrate passes from the blood chamber through the semipermeable membrane into the filtrate chamber 1253. In hemodiafiltration, a process that uses both diffusive and convective methods, filtrate also passes from the blood chamber through the semipermeable membrane into the filtrate chamber 1253, which is pumped into a filtrate container 1285 by the filtrate pump 1240 in the medical tubing 3000. The fluid to be discarded in the medical tubing 3000, whether referred to as dialysate or filtrate or simply as effluent, flows through a tubing section 3100 on which an optical blood leak detector 1295 is arranged, before being collected in the dialysate container, filtrate container, or effluent container 1285 for disposal.The terms dialysate, filtrate, and effluent are used synonymously for the fluid to be disposed of in the present invention, since the blood treatment method used to obtain the fluid to be disposed of is irrelevant for the present invention. The optical blood leak detector 1295 detects blood or blood components in the dialysate, filtrate, or effluent with a specific sensitivity as it flows through the tubing section 3100 at a specific flow rate. In some embodiments, the extracorporeal blood circuit can have various pressure measuring points, namely a pressure measuring point 1290 upstream of the blood pump, a pressure measuring point 1291 downstream of the blood pump, and a pressure measuring point 1293 on the return line or venous line 1270, in particular on the air bubble separator or the venous chamber 1284.In some embodiments, a substitution fluid line with a substitution fluid container 1280, a substitution fluid pump 1230, and a substitution fluid heating bag 1281 may additionally be provided. In Figure 1, the substitution fluid line is shown as an example on the return line or venous line 1270. Alternatively or additionally, a corresponding arrangement of a further substitution fluid line with a further substitution fluid container, a further substitution fluid pump, and a further substitution fluid heating bag may also be provided on the withdrawal line or arterial line 1260.
[0079] Figure 2 shows a schematic perspective view of a blood treatment device 1000 according to the invention for extracorporeal blood treatment.
[0080] Figure 2 schematically shows, on the front of the blood treatment device 1000, a dialysis fluid pump 1220 configured for functional coupling to a dialysis fluid pump tube segment 1221 (not shown in Figure 2), a substitution fluid pump 1230 configured for functional coupling to a substitution fluid pump tube segment 1231 (also not shown in Figure 2), a filtrate pump or effluent pump or dialysate pump 1240 configured for functional coupling to a filtrate pump tube segment 1241 (also not shown in Figure 2), and a blood pump 1210 configured for functional coupling to a blood line pump tube segment 1262 (also not shown in Figure 2). The aforementioned pump tube segments are components of the disposable tube set 4000 (see Figure 3).
[0081] In specific embodiments of a disposable tubing set 4000 according to the invention (see Figure 3), the disposable tubing set 4000 can be pre-equipped in or on an organizer or tray to facilitate functional coupling. The functional coupling of the disposable tubing set 4000 according to the invention, which is also referred to as a user-configured setup process, begins in such embodiments with the manual attachment of the organizer or tray to two hooks or pins 1500a and 1500b on the front of the blood treatment device 1000. As a result, all tubing set components to be functionally coupled hang in front of the associated machine-side actuators and sensors in a user-friendly manner. For example, the pump tubing segment of the arterial line 1260 is arranged by means of the tray or organizer such that the blood line pump tubing segment 1262 hangs directly in front of the blood pump 1210 in a user-friendly manner.This prevents errors during setup due to accidentally swapping tube sections and enables a particularly quick and user-friendly setup process, which is particularly important in intensive care or emergency medicine in intensive care units.
[0082] In specific embodiments, additional pumps may be added, for example, a heparin pump for performing heparin anticoagulation and / or for performing regional anticoagulation, a citrate pump for pumping a citrate-containing medical solution, and a calcium pump for pumping a calcium-containing medical solution. In such embodiments, the disposable tubing set 4000 additionally comprises at least one heparin line that opens into the arterial blood line or withdrawal line, a citrate line that also opens into the arterial blood line or withdrawal line, and a calcium line that opens into the venous blood line or return line.
[0083] Figure 3 shows an embodiment of the disposable tubing set 4000, which is arranged on an organizer or tray in a user-friendly and confusion-proof manner. The organizer or tray consists, for example, of a thermoformed plastic film and has recesses or openings in the area of the pumps. The recesses simultaneously form two eyelets 1501a and 1501b, and are configured for suspending and aligning the disposable tubing set 4000 on the two hooks or pins 1500a and 1500b on the front of the blood treatment device 1000, as shown in Figure 2. In the embodiment shown in Figure 3, the disposable tubing set 4000 comprises a blood tubing line or withdrawal line or arterial line 1260 with a blood line pump tubing segment 1262 and a return line or venous line 1270 with an air bubble separator or venous chamber 1284.Furthermore, a dialysis fluid pump tube segment 1221 is a.
[0084] Substitution fluid pump hose segment 1231 and a filtrate pump hose segment 1241 are shown. The pump hose segments 1262, 1221, 1231 and 1241 are positioned and fixed on the organizer or tray in such a way that, when the organizer or tray is suspended from the two hooks or pins 1500a and 1500b on the front of the blood treatment device 1000, they are aligned and assigned in front of the roller pumps in a user-friendly and confusion-proof manner (see Figure 2) and can be functionally coupled by the user in a confusion-proof manner to the respective intended roller pump or inserted into it for functional coupling.
[0085] The dialysis fluid line has a dialysis fluid heating bag 1283 and the substitution fluid line has a substitution fluid heating bag 1281.
[0086] Figure 4 shows the infusion rod 1700 with hook 1701 on the blood treatment device 1000 from Figure 2 as a detail with a fluid container 1800 suspended therefrom, in this example a solution bag 1800 filled with a priming fluid 1801. Due to gravity, the priming fluid forms a fluid level 1802. The priming fluid can be, for example, a sterile physiological NaCl solution. The arrow with the letter "g" in Figure 4 symbolizes the direction of gravitational acceleration.
[0087] As can be seen from Figure 4 in conjunction with Figure 2, when the user is in front of the blood treatment device 1000 and sees the liquid container 1800 as shown in Figure 4, they can see and monitor the liquid level of the priming liquid (1802) because the liquid container is at least partially transparent. In the present example, it is a solution bag made using plastic film that is at least partially transparent. The solution bag 1800 has an outlet connection 1810, in this example a short section of tubing with a connector 1820. The connector 1820 can be designed as one half of a Luer-Lock connector. In the example, the connector half 1820 is connected to an optional transfer tubing 1830 with a corresponding complementary connector half and an optional shut-off valve 1840.The optional shut-off valve 1840 has a connection for the arterial patient connector 1261a of the disposable tubing set 4000 from Figure 3. In Figure 4, the fluid container 1800 is connected in the manner shown to the arterial patient connector 1261a of the disposable tubing set 4000 according to Figure 3, so that after the user manually opens the shut-off valve, the priming fluid can flow into the withdrawal line 1260, also referred to as the arterial line 1260, of the disposable tubing set 4000, at least under the influence of gravity. The disposable tubing set 4000 according to Figure 3 is indicated in Figure 4 only in the form of an arterial patient connector 1261a on the withdrawal line and is shown broken off with a freehand line. Figure 4 thus shows the liquid container 1800 fully equipped for priming on the infusion rod 1700 of the blood treatment device 1000 from Figure 2.
[0088] Figure 5 shows a schematic view of the upper section of the blood treatment device 1000 from Figure 2, including the screen 1100 with touchscreen 1110 and the liquid container 1800 on the infusion pole 1700, as known from Figure 4, during the priming according to the invention. In Figure 5, the upper section of the blood treatment device 1000 shown is again shown broken off at the bottom by a freehand line. Figure 5 further shows a control and regulating device 1600 of the blood treatment device 1000, schematically represented by dashed lines.
[0089] The schematic representation of the touchscreen 1110 shows a first input button 1130, a second input button 1140, and an optional third input button 1150. The second input button 1140 and the optional third input button 1150 are shown with dashed lines to indicate that these input buttons do not have to be displayed simultaneously with the first input button 1130 in every display state of the touchscreen.
[0090] In some embodiments, there is a first display state of the touchscreen in which initially only the first input button 1130 is displayed. In a second display state of the touchscreen, which may follow the first display state of the touchscreen in time, it may be provided that the second input button 1140 and optionally the third input button or only the second input button 1140 are additionally displayed. In the second display state of the touchscreen, the first input button 1130 is optionally not displayed at all or optionally only displayed in gray and is then without function. The exact 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 predetermined for ergonomic reasons.In some embodiments, in the second display state of the touchscreen, the second input button 1140 may be displayed at the position and instead of the first input button 1130 from the first display state of the touchscreen.
[0091] Figure 5 shows, as already shown in Figure 2, the control and regulation device 1600 of the blood treatment device 1000, schematically represented by dashed lines.
[0092] Figure 6 shows a flowchart of an embodiment of the method according to the invention. Figure 6 shows which method steps the control and regulation device performs in the exemplary embodiment of the method according to the invention. The first method step consists of displaying a user interface G1 on the touchscreen of the blood treatment device for extracorporeal blood treatment. A graphical output area for text with a text T1 directed at the user and a first input button E1 are displayed. In the exemplary embodiment, the text T1 reads, for example:
[0093] “Fluid container with priming fluid connected to the extracorporeal blood tubing set?
[0094] Start automatic priming fluid delivery?
[0095] Optionally, a third input button E3 is displayed, with which the priming can be alternatively aborted or discarded without being performed and finally.
[0096] Again optionally, a timeout routine can run in the control and regulation device while the user interface G1 is displayed. A timer with a time limit can run, and priming can be automatically aborted when the time limit is reached or exceeded for the first time and the control and regulation device has not detected any actuation of the first input button E1 or the third input button E3 within the time limit.
[0097] When the user presses the first input button E1, the control and regulation device executes the automatic "first step" P1. The control and regulation device activates the blood pump, which pumps the priming fluid into the extracorporeal blood tubing set at a predetermined target flow rate. The control and regulation device continuously determines and stores the integral volume of the pumped priming fluid and stops the blood pump when the determined integral volume of the pumped priming fluid reaches or exceeds a predetermined first limit for the first time. The "first step" P1 of automatic priming is thus completed. A residual amount of priming fluid intentionally remains in the fluid container, in this example 5%.
[0098] A user interface G2 is then displayed on the touchscreen. It displays a graphical output area for text with a text T2 addressed to the user and a second input button E2. In the exemplary embodiment, the text T2 reads, for example:
[0099] “Continue pumping the priming fluid manually to completely empty the fluid reservoir?”
[0100] When the user presses the second input button E2, the control and regulation device proceeds to the “second step” P2. The control and regulation device activates the blood pump, which pumps the priming fluid into the extracorporeal blood tubing set at a predetermined target flow rate. The user manually determines how long the blood pump will pump. In the exemplary embodiment, for example, the blood pump pumps as long as the user keeps the second input button E2 pressed and stops the blood pump when the user no longer presses the first input button E2. By pressing the first input button E2 again, the blood pump can be restarted and further priming fluid can be pumped. It is at the user’s discretion whether to stop the blood pump in time or not to restart it when or as soon as the fluid container is visibly empty.For this purpose, the user observes the decreasing liquid level in the liquid container with priming liquid during the “second step” P2, whereby the liquid container with priming liquid hangs on the infusion rod of the blood treatment device in a manner clearly visible to the user, as shown in Figure 5.
[0101] Optionally, the third input button E3 can also be displayed on the user interface G2, which can be used to either terminate priming or to navigate to the user interface G3. In other words, by pressing the input button E3 on the user interface G2, the user can reject or skip the offered function of manually continuing the delivery of the priming fluid and accept that the fluid container is not completely emptied. In the exemplary embodiment, a case distinction is requested when pressing the input button E3 because, for example, it can happen that the fluid container is empty, but priming should continue with another, new fluid bag.For example, the user can reject or skip a manual continuation of the priming fluid delivery by briefly pressing the input button E3 once and immediately call up the user interface G3. Alternatively, the user can cancel the priming process by pressing the input button E3 for a longer period of time, for example, longer than 3 seconds. For this purpose, an instructional note can be displayed as text T2 or within text T2. If a manual continuation of the priming fluid delivery is rejected or skipped, the user interface G3 is immediately displayed.
[0102] Optionally, the control and regulation device can automatically abort the manual priming of step P2 when a termination criterion is met, for example, when a second limit value for the amount of priming fluid pumped is reached. This can prevent uncontrolled and unnoticed manual continuation of the blood pump, especially well beyond emptying the fluid container. This performs a plausibility check and, if necessary, automatically aborts the "second step" P2.
[0103] Again optionally, a timeout routine can run while the user interface G2 is displayed in the control and regulation device. A timer with a time limit can run in the control and regulation device while the user interface G2 is displayed, and priming can be terminated when the time limit is reached or exceeded for the first time and the control and regulation device has not detected any actuation of the second input button E2 or the third input button E3 within the time limit. The timer can be displayed on the user interface G2. This allows the user to see how much time remains to confirm one of the input buttons before priming is automatically terminated.The timeout routine prevents the control and regulation device from permanently remaining on the display of the G2 user interface if no input button is pressed for a long time, for example if the user suddenly has to turn to other tasks with a higher priority.
[0104] Alternatively or additionally, a timeout routine with a clock can also be provided on the optional user interfaces G1 and / or G3 and is indicated in Figure 6 in the user interfaces G1, G2 and G3 by means of a timer symbol.
[0105] After completing the second step P2 or briefly pressing the input button E3 of the user interface G2, a user interface G3 is displayed on the touchscreen. This displays a graphical output area for text with a text T4 directed at the user and a fourth input button E4. In the exemplary embodiment, the text T4 reads, for example:
[0106] “Should priming be continued with priming fluid from another, new fluid container?”
[0107] “New fluid container with priming fluid connected to the extracorporeal blood tubing set?”
[0108] If the user presses the fourth input button E4, thereby answering both questions in text T4 with yes, the control and regulation device executes the "first step" P1 of automatic priming again. In other words, the flowchart in Figure 6 returns to function P1.
[0109] Optionally, the third input button E3 is also displayed on the user interface G3, with which the priming can be finally aborted if the priming is not to be continued at the end.
[0110] The method according to the invention shown in the flow chart of Figure 6 can be carried out several times in succession.
[0111] The texts T1, T2, and T4 can optionally be displayed sequentially, with the text of the previous user interface being overwritten when a new user interface is displayed. The same applies to the input buttons E1, E2, E3, and E4.
[0112] The sequence of steps R1, E2, P2, E4, and again P1 can also be repeated several times in a loop until a prescribed amount of priming fluid has been pumped from several fluid containers into the extracorporeal blood tubing set. For example, one, two, three, or even more fluid containers can be used consecutively for priming.
[0113] According to the invention, the objects of the present invention are achieved with the described embodiment. However, the present invention is not limited to the embodiment.
[0114] List of reference symbols
[0115] 1000 blood treatment device for extracorporeal blood treatment
[0116] 1100 screen
[0117] 1110 touchscreen
[0118] 1120 Graphic output area for text and / or symbols
[0119] 1130 first input button
[0120] 1140 second input button
[0121] 1150 third input button
[0122] 1160 fourth input button
[0123] 1210 Blood pump
[0124] 1215 Heparin pump
[0125] 1220 Dialysis fluid pump
[0126] 1221 Dialysis fluid pump tubing segment
[0127] 1230 Substitution fluid pump
[0128] 1231 Substitution fluid pump hose segment
[0129] 1240 filtrate pump, effluent pump, dialysate pump
[0130] 1241 Filtrate pump hose segment
[0131] 1250 blood treatment module, dialyzer, blood filter
[0132] 1251 semipermeable membrane
[0133] 1252 Blood Chamber
[0134] 1253 dialysate chamber, filtrate chamber
[0135] 1260 Blood line, sampling line, arterial line 1261 Sample clamp or arterial clamp
[0136] 1261 a arterial patient connector
[0137] 1262 Blood line pump tubing segment
[0138] 1270 Return line, venous line
[0139] 1271 Return clamp, venous clamp
[0140] 1271 a venous patient connector
[0141] 1280 substitution fluid containers
[0142] 1281 Substitution fluid heating bag
[0143] 1282 Dialysis fluid container
[0144] 1283 Dialysis fluid heating bag
[0145] 1284 Air bubble separator, venous chamber
[0146] 1285 Filtrate container, effluent container, dialysate container
[0147] 1286 Heparin containers
[0148] 1290 Pressure gauge upstream of the blood pump
[0149] 1291 Pressure gauge downstream of the blood pump
[0150] 1292 Pressure gauge return pressure, venous pressure
[0151] 1295 optical blood leak detector
[0152] 1300 hose holder
[0153] 1500 a, 1500 b hook, pin
[0154] 1600 Control and regulation device
[0155] 1700 Hanging device, infusion pole
[0156] 1701 Infusion pole hook 1800 Liquid container, solution bag
[0157] 1801 Priming fluid
[0158] 1802 Priming fluid level
[0159] 1810 Liquid container outlet connection
[0160] 1820 Connector of the liquid container outlet port
[0161] 1830 Transfer hose line
[0162] 1840 Shut-off valve of the transfer hose line
[0163] 3000 medical hose lines
[0164] 3100 hose section
[0165] 4000 Disposable Hose Set g Gravitational Acceleration, with arrow pointing in the direction of gravity
Claims
Patent claims 1. A medical blood treatment device (1000) for extracorporeal blood treatment by means of an extracorporeal blood tubing set with a blood treatment module, comprising at least one device for suspending at least one liquid container (1800) filled with a predetermined initial volume of priming liquid, at least one blood pump (1210) with a rotor and a motor drive, which is configured for functionally coupling a line section of the extracorporeal blood tubing set, in particular a pump tubing segment (1262), wherein the blood pump (1210) has a device for detecting the number of revolutions and / or the angle of rotation of the rotor, a control and regulating device (1600) with a memory, a screen (1100) with a touchscreen (1110) in signal connection with the control and regulating device (1600),wherein the control and regulating device (1600) is programmed to display on the touchscreen (1110) a graphic output area for text and / or pictorial representation and at least one first input button (1130) for starting the automatic conveyance of the priming fluid by means of the blood pump (1210) and a second input button (1140), wherein the control and regulating device (1600) is signal-connected to the motor drive for controlling the motor drive with a control voltage during a running time of the blood pump (1210), and is signal-connected to the device for detecting the number of revolutions and / or the angle of rotation of the rotor, and is programmed to control and / or regulate the blood pump (1210) with a, predetermined target delivery rate for delivering the priming fluid in the extracorporeal blood tubing set, and wherein the control and regulating device (1600) is programmed to continuously determine and store the amount of the integral volume of the delivered priming fluid based on (i) the running time of the blood pump or (ii) the number of revolutions of the rotor performed or (iii) the angle of rotation of the rotor performed or (iv) the control voltage of the motor drive, and to store the predetermined amount of the initial volume of the priming fluid of the fluid container (1800), characterized in that the control and regulating device (1600) is additionally programmed such that a predetermined first limit value for a first partial volume of the priming fluid is stored in the memory, which is smaller than the amount of the initial volume of the priming fluid in the fluid container (1800),and when an actuation of the first input button (1130) is detected, the blood pump (1210) is controlled to automatically deliver the priming fluid at the predetermined target delivery rate, and when the determined integral volume of the delivered priming fluid has reached or exceeds the predetermined first limit value for the first time, the automatic delivery of the priming fluid is stopped and at least the second input button (1140) is displayed on the touchscreen (1110) and a user message is displayed on the graphical output surface by means of text and / or imagery that the delivery of the priming fluid can be continued manually by actuating the second input button, and when an actuation of the second input button (1140) is detected, the delivery of the priming fluid by means of the blood pump (1210) is restarted.
2. Medical blood treatment device according to claim 1, characterized in that the control and regulating device (1600) is additionally programmed to automatically terminate the priming if no actuation of the second input button (1140) is detected within a predetermined time limit.
3. Medical blood treatment device according to claim 1 or 2, characterized in that the control and regulation device (1600) is additionally programmed, when the automatic delivery of the priming liquid is stopped, to additionally display a third input button (1150) on the touchscreen (1110) and to additionally display a user instruction on the graphical output surface by means of text and / or image representation that by pressing the third input button (1150) (i) the priming can be finally ended, or that (ii) by pressing the third input button (1150) a manual continuation of the delivery of the priming liquid can be rejected, skipped or ended and, if an actuation of the third input button (1150) is detected,(i) to terminate the priming process or (ii) to reject, skip, or terminate a manual continuation of the delivery of the priming fluid and / or if no actuation of the third input button (1150) is detected within a predetermined time limit, to terminate the priming process automatically.
4. Medical blood treatment device according to one of claims 2 to 3, characterized in that the control and regulating device (1600) is additionally programmed to display a fourth input button (1160) on the touchscreen (1110) and to additionally display a user instruction on the graphical display by means of text and / or image representation. Output area to show that by pressing the fourth input button (1160) the delivery of priming fluid from a further fluid container (1800) which is filled with the predetermined initial volume of priming fluid can be started and, if an actuation of the fourth input button (1160) is detected, the blood pump (1210) is controlled to start the delivery of priming fluid from the further fluid container (1800).
5. Medical blood treatment device according to one of claims 1 to 4, characterized in that the control and regulating device (1600) is programmed such that the first limit value stored in the memory is 1% to 10%, preferably 3% to 7%, particularly preferably 4% to 6% smaller than the amount of the initial volume of the priming liquid in the liquid container (1800).
6. Medical blood treatment device according to one of claims 1 to 5, characterized in that the control and regulating device (1600) is additionally programmed, after detecting an actuation of the second input button (1140), to continue the delivery of the priming liquid as long as a continuous actuation of the second input button (1140) is detected and to stop the delivery of the priming liquid when it is detected that the second input button (1140) is no longer actuated.
7. Medical blood treatment device according to one of claims 1 to 5, characterized in that the control and regulation device (1600) is additionally programmed to continue the delivery of the priming liquid at a predetermined interval after detecting an actuation of the second input button (1140), and to always continue the delivery of the priming liquid again at the predetermined interval if a renewed actuation of the second input button (1140) is detected, wherein the predetermined interval is limited by a termination criterion selected from the group (i) a predetermined number of rotor revolutions n = 1 to 10 or a predetermined angle of rotation or (ii) a predetermined delivery volume from the value range V = 1 ml to 50 ml or (iii) a predetermined time interval from the value range t = 1 s to 10 s.
8. Medical blood treatment device according to one of claims 1 to 7, characterized in that the control and regulating device (1600) is additionally programmed to store a predetermined second limit value for the maximum permissible volume of the total priming liquid to be pumped, and to automatically terminate the priming as soon as the volume of the pumped priming liquid has reached the predetermined second limit value or exceeds it for the first time.
9. A method for priming an extracorporeal blood tubing set on a blood treatment device for extracorporeal blood treatment (1000), comprising the steps: Providing a medical blood treatment device (1000) according to one of claims 1 to 8, at least one liquid container (1800) filled with a predetermined initial volume of priming liquid, and an extracorporeal blood tubing set with a blood treatment module (1250), by the user hanging the at least one liquid container (1800) with priming liquid on the at least one hanging device (1700), in particular on the infusion rod (1700), by the user functionally coupling a line section of the extracorporeal blood tubing set, in particular a pump tube segment (1262), to the blood pump (1210), by the user, fluid-conducting connection of the fluid container (1800) to a hose line of the extracorporeal blood tubing set by the control and regulating device (1600); display of a graphic output area for text and / or image representation and at least one first input button (1130) for starting the automatic delivery of the priming fluid by means of the blood pump (1210) on the touchscreen (1110) by the control and regulating device (1600); detection of an actuation of the first input button (1130) and then actuation of the blood pump (1210) to effect automatic delivery of the priming fluid by means of the blood pump (1210); by the control and regulating device (1600), stopping the automatic delivery of the priming fluid when the determined volume of the delivered priming fluid has reached a predetermined first limit value or exceeds it for the first time,and displaying on the touchscreen (1110) at least one second input button (1140) and the user message on the graphical output area that the delivery of the priming fluid by means of the blood pump (1210) can be manually continued by actuating the second input button (1140), restarting the delivery of the priming fluid by means of the blood pump (1210) by the control and regulating device (1600) when an actuation of the second input button (1140) is detected.
10. A method for priming according to claim 9, characterized by the additional step: by the control and regulating device (1600) automatic final termination of the priming if no actuation of the second input button (1140) is detected within a predetermined time limit.
11. A method for priming according to one of claims 9 to 10, characterized by the additional steps of the control and regulation device (1600): after stopping the automatic delivery of the priming liquid, displaying on the touchscreen (1110) additionally a third input button (1150) and additionally a user message on the graphical output area that by pressing the third input button (1150) (i) the priming can be finally terminated or (ii) that by pressing the third input button (1150) a manual continuation of the delivery of the priming liquid can be rejected, skipped or terminated and, if an actuation of the third input button (1150) is detected, (i) finally terminating the priming or (ii) rejecting or skipping or terminating the manual continuation of the delivery of the priming liquid and / or automatically finally terminating the priming,if no actuation of the third input button (1150) is detected within a predetermined time limit., 12. Method for priming according to one of claims 9 to 11, characterized by the additional steps of the control and regulation device (1600): Continuing the conveyance of the priming liquid as long as a continuous actuation of the second input button (1140) is detected and Stopping the delivery of the priming fluid when it is detected that the second input button (1140) is no longer pressed.
13. A method for priming according to one of claims 9 to 11, characterized by the additional step of the control and regulating device (1600): continuing the delivery of the priming liquid at a predetermined interval when an actuation of the second input button (1140) is detected and always re-continuing the delivery of the Priming fluid at the predetermined interval when a renewed actuation of the second input button (1140) is detected, wherein the predetermined interval is limited by a termination criterion selected from the group (i) a predetermined number of rotor revolutions n = 1 to 10 or a predetermined angle of rotation or (ii) a predetermined delivery volume from the value range V = 1 ml to 50 ml or (iii) a predetermined time interval from the value range t = 1 s to 10 s.
14. A method for priming according to one of claims 9 to 13, characterized by the additional step of the control and regulating device (1600): automatically terminating the priming as soon as the volume of the pumped priming liquid has reached or for the first time exceeds a predetermined second limit value.
Citation Information
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