Method for checking an equipping state of a blood treatment device, and devices
The method and system for verifying the loading status of blood treatment devices using pressure sensors address the risk of misinserted or improperly connected heating bags, ensuring safe and reliable operation by detecting and preventing inadequate heating.
Patent Information
- Application Number
- PCT/EP2025/054428
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-02-22
- Filing Date
- 2025-02-19
- Publication Date
- 2025-08-28
AI Technical Summary
Existing blood treatment devices risk patient safety due to the potential misinsertion or improper connection of heating bags for dialysis fluid, leading to inadequate heating, which can occur without proper verification methods.
A method and system for checking the loading status of a blood treatment device by using pressure sensors to verify the presence and functionality of heating bags and flow resistance mechanisms in the dialysis fluid tubing system, including automatic evaluation and output of verification results.
Ensures the safe and reliable operation of blood treatment devices by detecting improper installations or connections, preventing potential patient risks and ensuring consistent fluid heating, particularly in critical care scenarios.
Smart Images

Figure EP2025054428_28082025_PF_FP_ABST
Abstract
Description
[0001] Description
[0002] Method for checking a loading status of a blood treatment device, and devices
[0003] The present invention relates to a method according to the preamble of claim 1, a control device according to the preamble of claim 12 and a blood treatment device according to the preamble of claim 13. Furthermore, the present invention relates to a digital storage medium according to claim 16, a computer program product according to claim 17 and a computer program according to claim 18 or according to the respective preambles or generic terms of these claims.
[0004] WO 2013 / 135365 discloses devices by which dialysis fluid, which flows through a heating bag inserted into a heating device during a dialysis treatment, is heated. The heating occurs as the fluid flows through the heating bag, which is heated via its outer wall by the heating device, before the dialysis fluid is introduced into the dialyzer or blood treatment filter, in which a substance exchange takes place between the blood and the dialysis fluid via a - usually semipermeable - membrane. Treatment devices other than the dialysis device mentioned here, as well as examination devices, also regularly feature such heating devices.
[0005] However, under certain operating conditions, without taking countermeasures, it cannot be ruled out that the heating bag was accidentally not inserted into the designated receptacle of a heating device, usually a medical one, or was not connected to safety elements such as a check valve, which is why the medical fluid used is not heated or not heated as planned, which could pose a risk to the patient during the subsequent treatment or examination.
[0006] An object of the present invention is to propose a method for checking the loading status of a blood treatment device, particularly in the context of a heating bag for dialysis fluid. Furthermore, suitable devices are to be specified.
[0007] The object of the invention is achieved by the method for checking the equipment status of a blood treatment device having the features of claim 1. It is further achieved by means of the control device having the features of claim 12, the blood treatment device having the features of claim 13, the digital storage medium having the features of claim 16, the computer program product having the features of claim 17, and the computer program having the features of claim 18.
[0008] Thus, a method for checking an equipment status of at least one blood treatment device relating to a dialysis fluid hose system is proposed.
[0009] The method comprises providing the blood treatment device. The blood treatment device comprises a blood pump, a dialysis fluid pump, a plurality of pressure sensors, and at least one first heating device (which may be the only heating device of the type of blood treatment device) having a first receiving portion (which may be the only receiving portion of this type of heating device) for receiving a first heating bag for heating medical fluid flowing through it.
[0010] The method further comprises providing an extracorporeal blood circuit, inserting a portion thereof into the blood pump, and at least partially filling the extracorporeal blood circuit with fluid.
[0011] The method according to the invention also includes providing a dialysis fluid tubing system, wherein the dialysis fluid tubing system has at least one dialysis fluid inlet line with a first heating bag integrated therein. The dialysis fluid tubing system preferably further comprises a closure mechanism for closing a flow-through lumen of the dialysis fluid tubing system downstream of the first heating bag and / or preferably at least one device for generating or changing a flow resistance in the dialysis fluid tubing system downstream of the first heating bag. Alternatively, the dialysis fluid tubing system consists of the aforementioned components.
[0012] The method further comprises inserting the first heating bag into the receiving section of the first heating device. Furthermore, the method comprises the following mechanical, preferably automatically executed and / or initiated steps.
[0013] The method thus comprises building up pressure within at least one section of the extracorporeal blood circuit by means of the blood pump and determining the pressure prevailing after the pressure has been built up or this pressure within the extracorporeal blood circuit. For this purpose, the existing pressure sensors or pressure values measured by them in the dialysis fluid tubing system and / or extracorporeal blood circuit can be used or are employed. Determining the prevailing pressure provides a pressure value and / or a pressure development of the prevailing pressure, which can be evaluated based on at least one first predetermined criterion. The result of this evaluation can be, for example, that a functional closure mechanism is arranged in the dialysis fluid tubing system downstream of the first heating bag, or is not arranged.
[0014] The method also encompasses the output of a verification result, also referred to herein as the first verification result, or a consequence thereof or a signal thereon based on the result of the evaluation. The output may be signal-based, e.g., it may be optical, acoustic, etc. The output may, in particular, serve to inform the user, but may also have other consequences, for example, as explained further below.
[0015] When reference is made herein to a "user," this refers to a person who has the necessary know-how to use the blood treatment device, in particular to treat a patient with it and to carry out the necessary steps prior to the treatment on the blood treatment device. This notation does not provide any information as to the gender or other characteristics of this person.
[0016] When reference is made here to a "patient," it means a person whose blood requires treatment. This notation provides no information about the gender or other characteristics of this person.
[0017] “User” and “patient” usually do not belong to the same group of people.
[0018] The invention further comprises a control device, which can be a control and / or regulating device. This is configured to initiate or carry out, control and / or regulate the method according to the invention or its mechanical steps in cooperation by means of a provided blood treatment device - in particular automatically - in particular as disclosed herein. The blood treatment device connected to the control and / or regulating device has a blood pump, a dialysis fluid pump, a plurality of pressure sensors and at least one first heating device, which in turn has a first receiving section for receiving a first heating bag for heating medical fluid flowing through it during use.The blood treatment device may already have, or be equipped with, an extracorporeal blood circuit with a section inserted into the blood pump, a dialysis fluid tubing system, in particular as described herein, and a heating bag inserted into the first receiving section of the first heating device. The control and / or regulating device may be configured to control or regulate such a blood treatment device.
[0019] An interaction can be or include a control, regulation, or regulation. An interaction can be or require a signal connection.
[0020] The blood treatment device further comprises or is connected to an extracorporeal blood circuit, at least a section of which is inserted into the blood pump and at least partially filled with fluid. The blood treatment device further comprises a dialysis fluid hose system, which in turn comprises at least one dialysis fluid inlet line with a first heating bag integrated therein and a closure mechanism for closing a flow-through lumen of the dialysis fluid hose system downstream of the first heating bag, alternatively or additionally at least one device for generating or changing a flow resistance in the dialysis fluid hose system downstream of the first heating bag, or consists thereof.
[0021] When reference is made herein to a "closure mechanism for closing a flow-through lumen of the dialysis fluid tubing system", a "device for generating or changing a flow resistance in the dialysis fluid tubing system", a "check valve" or a "throttle", these terms are interchangeable in certain embodiments. This means that what is said herein regarding the throttle or check valve can also be read in some embodiments as referring to a closure mechanism or a device for generating or changing a flow resistance, unless technically impossible. This applies, for example, to an arrangement downstream of the heating bag.
[0022] The control device may be or include an evaluation unit for evaluating as disclosed herein based on the first and / or further predetermined criteria.
[0023] The blood treatment device according to the invention comprises a blood pump, a dialysis fluid pump, a plurality of pressure sensors arranged to measure a pressure within an extracorporeal blood tubing set and / or a dialysis fluid tubing system in use, at least one first heating device and a control device according to the invention or is connected to such components.
[0024] The first heating device serves to heat a liquid, in particular dialysis liquid or substituate liquid, and in turn has a first receiving section for receiving a first heating bag through which a liquid can flow in order to heat it.
[0025] Furthermore, the blood treatment device has a control device according to the invention or is connected thereto.
[0026] The control device can be part of the control and / or regulating device of the blood treatment device. A storage medium according to the invention, in particular digital, in particular non-volatile, (here also referred to as a carrier), in particular in the form of a floppy disk, RAM, ROM, CD, hard disk, DVD, USB stick, flash card, SD card or EPROM, in particular with electronically or optically readable control signals, is configured in such a way as to configure or program a control device to form a control device according to the invention, by means of which the mechanical steps of the method according to the invention can be initiated.
[0027] All, some or some of the machine-performable steps of this process can be initiated in any combination.
[0028] A computer program product according to the invention has a volatile, fleeting or machine-readable program code, by means of which a control device is configured or programmed to form a control device according to the invention, by means of which the mechanical steps of the method according to the invention can be initiated.
[0029] In this case, all, some or some of the mechanically executable steps of this process can be initiated in any combination.
[0030] According to the invention, a computer program product can be understood as meaning, for example, a computer program stored on a carrier, an embedded system as a comprehensive system with a computer program (e.g. an electronic device with a computer program), a network of computer-implemented computer programs (e.g. client / server system, cloud computing system, etc.) or a computer on which a computer program is loaded, runs, is stored, executed or is developed.
[0031] The term "machine-readable medium" as used herein refers, in certain embodiments of the present invention, to a medium containing data or information interpretable by software and / or hardware. The medium may be a data carrier such as a floppy disk, a CD, a DVD, a USB stick, a flash card, an SD card, an EPROM, and the like.
[0032] A computer program according to the invention has a program code by means of which a control device is configured or programmed to form a control device according to the invention, by means of which the mechanical steps of the method according to the invention can be effected.
[0033] All, some or some of the machine-performable steps of this process can be initiated in any combination.
[0034] According to the invention, a computer program can be understood as meaning, for example, a physical, marketable software product which comprises a program.
[0035] The method discussed herein is the subject matter of the present invention and is therefore in accordance with the invention. The control device discussed herein is the subject matter of the present invention and is therefore in accordance with the invention. The blood treatment device discussed herein is the subject matter of the present invention and is therefore in accordance with the invention. The digital storage medium, computer program product and computer program discussed herein are each the subject matter of the present invention and are therefore each in accordance with the invention.
[0036] Embodiments of the invention may, based on any of the independent claims, comprise one or more of the features mentioned above or below. The features mentioned herein may, in any combination, be the subject of embodiments of the invention based on any of the independent claims, provided that a person skilled in the art does not recognize a specific combination as technically impossible.
[0037] In all the above and following statements, the use of the expression "may be" or "may have" etc. is to be understood as synonymous with "is preferably" or "preferably has" etc. and is intended to explain an embodiment of the invention.
[0038] Whenever numerical words are mentioned herein, the person skilled in the art will understand this as indicating a numerical lower limit. Unless this leads to a contradiction recognizable to the person skilled in the art, the person skilled in the art will therefore always read "at least one" or "at least one" as being used when referring to "a" or "an". This understanding is also encompassed by the present invention, as is the interpretation that a numerical word such as "a" can alternatively be meant as "exactly one", wherever this is recognizably technically possible to the person skilled in the art. Both are encompassed by the present invention and apply to all numerical words used herein. Whenever spatial information is mentioned herein, such as "above", "below", "left" or "right", the person skilled in the art will understand this to mean the arrangement in the figures attached here and / or in the state of use. "Below" is closer to the center of the earth or the lower edge of the figure than "above".
[0039] Whenever reference is made to "programmed" or "configured" herein, it is also disclosed that these terms are interchangeable.
[0040] Whenever reference is made here to determining a pressure, this can be done by measuring the pressure, by an indirect determination, an inference, and / or the like.
[0041] Advantageous further developments of the present invention are the subject of subclaims and
[0042] Forms of implementation.
[0043] Whenever an embodiment is mentioned herein, it is an exemplary embodiment of the invention, based on one of the independent claims, which is not to be understood as limiting.
[0044] If it is disclosed herein that the subject matter according to the invention has one or more features in a particular embodiment, it is also disclosed herein that the subject matter according to the invention expressly does not have precisely this or these features in other, likewise inventive embodiments, e.g., by way of a disclaimer. For each embodiment mentioned herein, the opposite embodiment, for example, formulated as a negation, is also disclosed.
[0045] Embodiments as disclosed herein further develop the invention as defined by the independent claims.
[0046] In some embodiments of the method, for each pressure, only the measurement results of exactly one sensor of the blood treatment device used are included in the evaluation, are evaluated according to one of the three criteria described herein and / or are included in the verification result.
[0047] When a heating device is mentioned herein, it can be used to heat a medical fluid, in particular dialysis fluid or substituate fluid. It can have a first receiving section for receiving a heating bag through which the fluid can flow for heating. This can be cylindrical to accommodate a cylindrical heating bag. It can have any other configuration, e.g., as a heating plate or surface for easy placement of the heating bag.
[0048] When reference is made herein to a heating bag, it can be designed as a bag or have any other design, e.g., as a heating cassette, heating plate(s), and / or heat exchanger cassette. Its outer wall can thus be flexible, inflexible, round in view, angular, cylindrical in terms of its volume, cuboid, etc. In the context of the present invention, a heating bag is understood to mean a cylindrical bag in certain embodiments; in others, a bag or a flat bag, a cassette, in particular a flat cassette, etc.
[0049] A heating bag can be a tubing section of the dialysis fluid tubing system or a line thereof with a larger circumference - e.g. compared to a supply line to the heating bag and / or a discharge line from the heating bag - or with a larger outer surface per unit length of the tubing set in the flow direction.
[0050] In some embodiments, after priming / flushing or after creating one or more predetermined initial conditions, all pumps, or at least the blood pump and the dialysis fluid pump, are stopped, and the venous hose clamp is closed. The stopped pumps are then activated sequentially. In this way, the functionality of the pressure sensors in the extracorporeal blood circuit and / or in the dialysis fluid hose system, particularly in the filtrate or dialysate drain line (here also referred to as the dialysate drain line for short), can be checked before continuing the method according to the invention.
[0051] In certain embodiments, after priming / flushing or after creating one or more predetermined initial conditions, the prevailing pressure in the extracorporeal blood circuit and / or in the dialysis fluid tubing system, in particular in the dialysate drain line, is determined before the method according to the invention is continued.
[0052] In some embodiments, the method further comprises a
[0053] Building up pressure within at least one section of the dialysis fluid tubing system by means of the dialysis fluid pump and (after building up the pressure) determining the pressure prevailing within the extracorporeal blood circuit by means of one of the pressure sensors. In this process, a pressure value and / or a pressure development of the prevailing pressure is achieved, determined, or ascertained (referred to simply as "achieved").
[0054] In these embodiments, the method further comprises evaluating the determined pressure value and / or the determined pressure development based on at least one predetermined criterion, which is also referred to herein as a second predetermined criterion.
[0055] The predetermined second criterion can be a temporal duration, a temporal offset or a time delay, also referred to herein as “delay”. For example, the pressure development in the extracorporeal blood circuit can be evaluated with regard to time. By way of example, it can be considered whether and, if so, when an expected pressure increase occurred and / or how much time has passed between the start of the dialysis fluid pump and a detected pressure increase in the extracorporeal blood circuit. The evaluation can be a comparison with reference values or the like. The result of the evaluation can in particular be whether a pressure response occurs outside a predetermined time range, whether it occurs too early or too late, in particular compared to a predetermined time period, how large a temporal offset is, etc.In these embodiments, the method optionally further comprises outputting a second verification result based on the result of this evaluation.
[0056] In some embodiments of the method, before the pressure is built up within at least one section of the extracorporeal blood circuit by means of the blood pump, and / or at least one section of the dialysis fluid tubing system by means of the dialysis fluid pump, at least this section is filled with fluid, in particular priming fluid or rinsing fluid.
[0057] In some embodiments, the method further comprises the step of creating predetermined initial conditions within the extracorporeal blood circuit before building up the pressure within at least one section of the extracorporeal blood circuit by means of the blood pump. The predetermined initial conditions can, for example, be stored in a memory device. They can, for example, be set or created automatically when the method is carried out.
[0058] In some embodiments, the creation of predetermined initial conditions is or includes setting a predetermined fluid level in a bubble chamber, a venous chamber, or a venous bubble trap of the extracorporeal blood circuit.
[0059] In some embodiments of the method, by considering the first and / or the second test result, it is at least determined whether the dialysis fluid tubing system has a closure mechanism for closing a flow-through lumen of the dialysis fluid tubing system downstream of the first heating bag and / or at least one device for generating or changing a flow resistance downstream of the first heating bag, and preferably before the blood filter or upstream of the blood filter.
[0060] In some embodiments of the method, before pressure is built up by means of the blood pump and before the determined pressure value and / or the determined pressure development is evaluated and / or before a first check result is output based on the result of the evaluation, the dialysis fluid pump is first actuated and, after a predetermined volume has been or should have been pumped along a section of the dialysis fluid tubing system, is stopped again.
[0061] The pressure now prevailing within the dialysis fluid tubing system is determined by means of one of the pressure sensors, whereby a pressure value and / or a pressure development of the prevailing pressure is obtained as a result of the determination.
[0062] An evaluation of the determined pressure value and / or the determined pressure development based on at least one predetermined criterion, also referred to herein as a third predetermined criterion, and the optional output of a third verification result based on the result of the evaluation is also included in these embodiments of the method. The third predetermined criterion can in some
[0063] In some embodiments, a predetermined reference pressure may be used.
[0064] In some embodiments, the third check result is used to determine whether the dialysis fluid tubing system is connected to the blood treatment device and / or whether the dialysis fluid tubing system is permeable to fluid.
[0065] This allows you to check whether clamps, e.g., those that are opened manually, are inadvertently still closed, which could inadvertently prevent subsequent treatment. In such a case, the pressure would not increase.
[0066] In some embodiments, the method is carried out and completed before the start of a treatment or examination of a patient by means of the blood treatment device, preferably after completion of the filling or priming of an extracorporeal blood circuit connected to the blood treatment device for an upcoming treatment or examination of the patient.
[0067] In some embodiments of the method, the closure mechanism for closing a flow-through lumen of the dialysis fluid tubing system downstream of the first heating bag and / or at least the device for generating or changing a flow resistance in the dialysis fluid tubing system downstream of the first heating bag is a check valve or a throttle or comprises one or more of the following. In some embodiments, the method further comprises, depending on the first, second and / or third check result, issuing an alarm by means of an alarm device, preventing the performance of a blood treatment or at least one treatment option by means of the blood treatment device and / or stopping the operation of the blood treatment device, in particular before the start of a blood treatment.Thus, if the first, second, and / or third inspection results raise concerns about the equipment or configuration status of the blood treatment device, or about the safety or well-being of the patient being treated, at least one of the above-mentioned measures can be taken. For example, if it is detected or suspected that a dialysis fluid tubing system was installed without a check valve or throttle, or with the wrong type of check valve or throttle (opening pressure), this can lead to at least one of the above-mentioned measures.
[0068] One equipping state can be understood as meaning that a functional closure mechanism for closing a flow-through lumen of the dialysis fluid tubing system is arranged downstream of the first heating bag, i.e., the dialysis fluid tubing system or the blood treatment device has been or is equipped with this. Another equipping state can mean that this is not the case.
[0069] A pressure development can be understood as a change in pressure over time, a pressure change or a pressure curve. The evaluation of the determined pressure measurement value and / or the determined pressure development based on a, in particular first, second or third, predetermined criterion comprises in some embodiments the inclusion of or comparison with expected values or ranges which can be taken from tables or memories, for example. This can include, for example, pressure values or pressure ranges, including those which one of the pressure sensors has determined or measured in earlier evaluations. The inclusion of such values can, for example, be a comparison. During the evaluation it can be checked whether the pressure measurement value and / or pressure development is below or above a threshold value, within or outside a reference range, etc.
[0070] Expected values, comparison values, or values in lookup tables or memories are preferably values that, when used as a reference, allow a statement as to whether a closure mechanism, as disclosed herein, is or was arranged and / or not in a dialysis fluid tubing system under consideration, in particular in its dialysis fluid supply line, downstream of the heating bag integrated therein. They have been generated accordingly.
[0071] In some embodiments, the method according to the invention does not take place, or no longer takes place, after the start of the treatment or examination of the patient, or ends before the start of the treatment.
[0072] In some embodiments of the blood treatment device, the control device is further configured to issue an alarm by means of an alarm device, to prevent a treatment option by means of the blood treatment device and / or to stop the operation of the blood treatment device depending on the first, second and / or third check result.
[0073] In some embodiments, the blood treatment device is configured as a blood purification device or dialysis device, as a filtration device, as a diafiltration device, or as a dialysis device in any other configuration known to those skilled in the art for blood purification, such as for hemodialysis, hemofiltration, or hemodiafiltration. It may be a plasmapheresis device.
[0074] What is stated herein regarding dialysis fluid also applies to substituate fluid in certain embodiments of the present invention. Likewise, what is stated here regarding dialysis fluid tubing systems also applies to substituate tubing systems in certain embodiments of the present invention.
[0075] In some embodiments, the dialysis fluid tubing system is a dialysis fluid tubing.
[0076] The blood treatment device is in certain
[0077] Embodiments configured for use in continuous venous hemodiafiltration, for example via CW-HDF, and / or for use in acute dialysis and / or for CKRT treatment.
[0078] In certain embodiments, the blood treatment device according to the invention is connected to an extracorporeal blood circuit. In some embodiments of the present invention, a heating bag is a section of a dialysis fluid tubing system that is dilated during filling and / or can be filled by radial and / or longitudinal expansion.
[0079] In certain embodiments of the present invention, a heating bag is a section of a dialysis fluid tubing system which has a thinner wall thickness than adjacent tubing sections.
[0080] A pressure development, as used herein, can refer to a pressure change as such, for example to the difference between an initial and a final pressure. Since in this consideration the changing pressure can be checked at different points in time, the term pressure development in some embodiments also includes the fact that the pressure development does not, for example, change in accordance with a predetermined reference pressure development, if the pressure does change and possibly in the right direction (increase, decrease), but the temporal progression with which this happens deviates unacceptably from a reference progression. If in one example the pressure had to double after a period of time T and only does so after 1.5 x T, or already after 0.5 x T, the pressure development may be objectionable.
[0081] The process according to the invention runs in some
[0082] Embodiments while the blood tubing set is connected to the blood filter. Some or all embodiments of the invention may have one, several, or all of the advantages mentioned above and / or below.
[0083] The present invention is easy to implement in existing systems, for example by retrofitting or reprogramming the control device, making use of existing components such as pumps, pressure sensors, etc.
[0084] Implementing the inventive teaching does not require a mechanical solution in the sense of moving parts, which can make it robust, simple to design, and low-maintenance. A significant advantage of the invention is the protection of the patient during use of the blood treatment device for treatment or examination.
[0085] Furthermore, a benefit of the present invention may be that a collapse of the heating bag and / or a manipulation / blockage of the dialysis fluid supply line, for example by means of a closed manual hose clamp, would be quickly noticed, which may contribute to a significant increase in patient safety, particularly in CW-HDF treatments.
[0086] A further advantage of the present invention can be that the use of an unqualified dialysis fluid tubing system can be detected prior to treatment of a patient by means of the method according to the invention. The use of an unqualified dialysis fluid tubing system would require an interruption of treatment and the replacement of the disposables during the course of treatment. Particularly in acute treatments in which critical care blood treatment devices (also known as acute dialysis machines or emergency dialysis devices) are used, e.g. for the treatment of AKI (Acute Kidney Injury) or for poisoning patients, especially in intensive care units, any avoidable interruption of treatment is prohibited in order not to endanger the patient. The present invention can therefore contribute to a significant increase in patient safety.
[0087] The present invention is explained below by way of example with reference to the accompanying drawings, in which identical reference numerals designate identical or similar components. In the figures of the drawing:
[0088] Fig. 1 shows an exemplary sequence of the method according to the invention in a first embodiment;
[0089] Fig. 2 shows a highly simplified process flow diagram of a blood treatment device according to the invention in one embodiment;
[0090] Fig. 3 shows, in a highly simplified form, the curve of a pressure profile within the dialysis fluid tubing system while checking whether the dialysis fluid inlet line is properly connected, illustrating part of the method in Fig. 1 by way of example; Fig. 4 shows, in a highly simplified form, the curve of a pressure profile within the extracorporeal blood circuit and / or within the filtrate or dialysate outlet line during the method according to the invention, illustrating part of the method in Fig. 1 by way of example;
[0091] Fig. 5 shows in a highly simplified form the curve of a pressure profile within the extracorporeal blood circuit and / or within the filtrate or dialysate discharge line during the method according to the invention, illustrating, by way of example, part of the method of Fig. 1; and
[0092] Fig. 6 shows an overview of the status of pumps, pressure sensors used and the condition of the hose clamps during individual steps of an optional embodiment of the method according to the invention in tabular form.
[0093] In the following descriptions of the figures, reference is made to the descriptions and reference symbols of the preceding and following figures.
[0094] Whenever reference is made here to the use of a pump, it is preferably the only pump running, i.e. all other pumps are stopped / not in operation.
[0095] Fig. 1 shows an exemplary sequence of a method according to the invention in a first embodiment.
[0096] Method step Ml represents the provision of a
[0097] Blood treatment device 100 (see also Fig. 2 for the reference symbols), comprising a blood pump 101, a dialysis fluid pump 121, several (optional) pressure sensors PS1, PS2, PS3, PS4, and at least one first heating device H_Dia. The at least one first heating device H_Dia has a first receiving section for receiving a first heating bag 123 for heating medical fluid flowing through it. See Fig. 2 in particular.
[0098] An optional provision of an extracorporeal blood circuit 300, an insertion of a section thereof into the blood pump 101 and an at least partial filling of the extracorporeal blood circuit 300 with liquid is represented by method step M2.
[0099] Furthermore, the method according to the invention in this embodiment, represented by method step M3, comprises an optional provision of a dialysis fluid tubing system having at least one dialysis fluid inlet line 120. A first heating bag 123 is integrated into the dialysis fluid inlet line 120, furthermore a closure mechanism for closing a flow-through lumen of the dialysis fluid tubing system downstream of the first heating bag 123 and / or at least one device for generating or changing a flow resistance in the dialysis fluid tubing system downstream of the first heating bag 123. Alternatively, the dialysis fluid inlet line 120 consists of this.
[0100] Method step M4 represents the insertion of the first heating bag 123 into the first receiving section of the first heating device H_Dia. The optional method step M4a represents the creation of predetermined initial conditions within the extracorporeal blood circuit 300 before pressure is built up within at least a section of the extracorporeal blood circuit 300 by means of the blood pump 101. Such creation of predetermined initial conditions can be or include, for example, setting a predetermined fluid level in a bubble chamber, a venous chamber, or a venous bubble trap 140 of the extracorporeal blood circuit 300. In some embodiments, this step can include stopping all pumps.
[0101] The optional method step M4b serves to check whether or not the dialysis fluid tubing system is in proper fluidic connection, for example, to the extracorporeal blood circuit 300, and / or is not blocked, for example, by means of a manual tubing clamp (not shown in Fig. 2). This step is discussed in more detail in Fig. 3.
[0102] Method step M5 includes building up pressure within at least one section of the extracorporeal blood circuit 300 by means of the blood pump 101. This and the following steps are described in more detail in Fig. 4.
[0103] Method step M6 represents a determination of the pressure prevailing after pressure has been built up within the extracorporeal blood circuit 300 by means of one of the pressure sensors PS1, PS2, PS3, PS4, while achieving a pressure value p cand / or a pressure development Ap of the prevailing pressure .
[0104] An optional evaluation of the determined pressure value p c and / or the determined pressure development Ap based on at least one first predetermined criterion is represented by means of method step M7.
[0105] In process step M8, an optional first verification result is output based on the result of the evaluation.
[0106] In method step M9, pressure is optionally built up within at least one section of the dialysis fluid tubing system using the dialysis fluid pump 121. This and the following steps are described in more detail in Figure 5.
[0107] An optional determination of the pressure prevailing (after pressure has been built up by means of the dialysis fluid pump 121) within the extracorporeal blood circuit 300 by means of one of the pressure sensors PS1, PS2, PS3, PS4 while achieving a pressure value p D and / or a pressure development Ap of the prevailing pressure is represented by means of the process step MI O .
[0108] In the process step Mi l, the determined pressure value p Dand / or the determined pressure development Ap is evaluated based on at least one predetermined criterion, also referred to herein as the second predetermined criterion. The predetermined second criterion can, for example, be a temporal duration or a temporal offset, also referred to herein as a "delay". The pressure development Ap in the extracorporeal blood circuit 300 can be evaluated with regard to time, i.e., for example, when did it occur and / or how much time has passed between the start of the dialysis fluid pump 121 and the pressure increase in the extracorporeal blood circuit 300.
[0109] An optional output of a second verification result based on the result of the evaluation in method step M11 is represented by method step M12.
[0110] Fig. 2 shows a highly simplified process flow diagram of an exemplary blood treatment device 100.
[0111] The blood treatment device 100 is optionally connected to an extracorporeal blood circuit 300 and further optionally to an effluent bag 400.
[0112] The extracorporeal blood circuit 300 has a first line 50, here in the form of an arterial line section, also referred to as a withdrawal line.
[0113] The first line 50 is optionally in fluid communication with a blood treatment device, here, for example, a blood filter or dialyzer 303. The blood filter 303 has a dialysis fluid chamber 303a and a blood chamber 303b, which are separated from each other by a mostly semi-permeable membrane 303c.
[0114] The extracorporeal blood circuit 300 further comprises at least one second line 60, here in the form of a venous line section, also referred to as a return line. Both the first line 50 and the second line 60 can serve to connect it to the vascular system of the patient (not shown).
[0115] The first line 50 is optionally connected to a (first) hose clamp 51 for blocking or closing the line 50. The second line 60 is optionally connected to a (second) hose clamp 61 for blocking or closing the line 60. In some embodiments, these hose clamps, or others, are closed to shut off the hose volume to be monitored.
[0116] The blood treatment device 100, represented schematically in Fig. 2 only by some of its devices, has a blood pump 101. During the treatment of the patient, the blood pump 101 pumps blood through sections of the extracorporeal blood circuit 300 and toward the blood filter or dialyzer 303, as indicated by the small arrowheads. Prior to a treatment session, the blood pump 101 serves to fill and flush parts of the treatment device 100 and sections of the extracorporeal blood circuit 300 with fluid.
[0117] By means of a first pump 121 for - here exemplarily ready-to-use - dialysis fluid, which can be designed in particular as a volumetric pump, fresh, - here exemplarily ready-to-use - dialysis fluid, e.g. from a first source 200, is conveyed towards or along a dialysis fluid supply line 120. The first source 200 can be a receptacle, for example a bag or a container. A second, optional source 210, which has a solution or liquid with a different, usually lower concentration than the provided, ready-to-use dialysis fluid of the first container 200, relating to the specific electrolyte, preferably sodium, for example table salt (NaCl) solution, is also provided. The second source 210 can also be a receptacle, for example a bag or a container.The second source 210 is also fluidly connected to an optional second pump 111 (also referred to herein as a substituate pump), which can also be configured, in particular, as a volumetric pump. With the pumps mentioned herein, it may be possible to supply substituate to the patient's blood via the substituate line 110 before it is returned to the body. The necessary measuring and / or dosing devices can be provided for this purpose.
[0118] The dialysis fluid leaves the dialysis fluid chamber 303a of the blood filter 303 as dialysate, optionally enriched with filtrate, via the dialysate outlet line 130 in the direction of the optional effluent bag 400 or to a spout and is referred to herein as effluent.
[0119] The elements and features discussed below can be provided optionally, in any combination of these elements and / or features. They can also be omitted individually or in any combination, unless deemed essential by a person skilled in the art for a specific combination of features. From the optional effluent bag 400, the effluent can be discarded into a sink via an effluent drain line. In some embodiments, the effluent is discarded directly into a sink via the dialysate drain line 130 (not shown here).
[0120] The dialysis fluid supply line 120 of Fig. 2 optionally has or is connected to a first heating bag 123. The first heating bag 123 is inserted into a first heating device H_Dia in order to supply heated dialysis fluid to the blood filter 303. This serves to counteract the cooling of the patient being treated.
[0121] The substituate line 110 leading from the second container 210 to the extracorporeal blood circuit 300 can have a second heating bag 125 or be connected to one. The second heating bag 125 can be inserted into an optional second heating device H_Sub to supply heated substituate to the extracorporeal blood circuit 300. This also serves to counteract cooling of the patient being treated, in this case due to added substituate.
[0122] In addition to the aforementioned blood pump 101 and the pump 121 for dialysis fluid, the arrangement shown in Fig. 2 can also optionally comprise a series of further, each optional pump; in Fig. 2, the filtrate pump 131 for the dialysate / effluent is shown as an example.
[0123] An arterial pressure sensor PS1 is optionally provided upstream of the blood pump 101. During patient treatment, it measures the pressure in the arterial line. Downstream of the blood pump 101, but upstream of the blood filter 303 and, if provided, preferably upstream of an addition point 25 for an anticoagulant, for example, heparin, another pressure sensor PS2 is optionally provided. It measures the pressure upstream of the blood filter 303 ("pre-hemo filter").
[0124] A further pressure sensor PS4 can be arranged downstream of the blood filter 303, but preferably upstream of the filtrate pump 131, in the filtrate or
[0125] Dialysate drain line 130 may be provided for measuring the filtrate pressure of the blood filter 303.
[0126] Blood leaving the blood filter 303, in particular its blood chamber 303b, flows through an optional venous bubble catcher 140, which may have a venting device and may be in fluid communication with a further pressure sensor PS3 for measuring the venous pressure.
[0127] In the example of the arrangement shown in Fig. 2, a throttle adapter T_Dia is located in the dialysis fluid supply line 120. A throttle adapter T_Sub is also provided, purely optionally, in the substituate line 110. A throttle adapter can be implemented as a check valve or have one. The throttle adapters T_Dia, T_Sub can be intended and / or suitable for being installed in the dialysis fluid supply line 120 or in the
[0128] Substituate line 110 to maintain an overpressure, which ensures that the, usually thin-walled, heating bags, which are inserted into the heating devices H_Dia or H_Sub, do not collapse, lie properly against the heating device H_Dia or H_Sub, etc.
[0129] A control or regulating device 150, which is only indicated, is configured to initiate or carry out a method for controlling or regulating the blood treatment device 100, in particular when it is in signal communication with the blood treatment device 100. It can optionally be further configured to otherwise control or regulate the blood treatment device 100, for example for treating the patient. It can be provided with any of the components mentioned herein - in any case or in particular with the pumps 111, 121, 131 and / or the blood pump 101 - in a wired or wireless signal connection for controlling or regulating the blood treatment device 100.
[0130] Fig. 3 shows in a highly simplified form the curve 1000 of a pressure curve within the dialysis fluid tubing system and / or within the extracorporeal blood circuit 300, illustrating, by way of example, part of the method of Fig. 1 (method step M4b).
[0131] The pressure curve shown in Fig. 3 is caused by actuation of the dialysis fluid pump 121, which can be used to check whether the dialysis fluid supply line 120 is properly connected.
[0132] The course of the curve 1000 in Fig. 3 can be determined by means of the control device 150 from the pressure values measured by the pressure sensors PS2, PS3, PS4 or determined in another way, such as p A , p B and / or further, are determined over time t and can be additionally displayed in a suitable manner if desired.
[0133] In some designs it may be sufficient to specify the pressure values pA , PB from a single one of the above-mentioned pressure sensors PS I, PS2, PS3, PS4 or their determined pressure development Ap, here exemplified as a simple pressure difference Ap B between the initial pressure p A and the final pressure p B , to consider .
[0134] One of these pressure sensors, for example the pressure sensor PS4 , may be preferred and it may be sufficient to use its pressure values p A , p B or its determined pressure development Ap . The curves between the determined pressure values p A , p B, or the pressure development Ap, which are or have been determined by the three pressure sensors PS2, PS3, PS4, respectively, show a similar curve, but can, for example, differ slightly, but mostly in a characteristic way, due to the separation properties of the membrane 303c and / or delays in the pressure build-up within the extracorporeal blood circuit 300 and / or the dialysate drain line 130. For this reason, the pressure sensor PS4 for determining the pressure in the dialysate drain line 130 is chosen as an example below and reference is made to it by way of example. Everything stated below regarding the pressure sensor PS4 for determining the pressure in the dialysate drain line 130 therefore also applies analogously to the pressure sensors PS1, PS2, PS3 and other, not shown, pressure sensors for determining the pressure in the extracorporeal blood circuit 300.
[0135] The diagram in Fig. 3 shows pressure values P (y-axis,
[0136] Ordinate axis ) , for example in the unit [hPa ] , over time t (x-axis , abscissa axis ) , for example in the unit seconds [ s ] .
[0137] In the example of Fig. 3, the continuous curve 1000 shows the course of the pressure values measured by the pressure sensor PS4 in the dialysate drain line 130 over time.
[0138] In the dialysate discharge line 130, for example after the creation of predetermined initial conditions, there is a pressure with the pressure value p A After actuation of the dialysis fluid pump 121 at time t1 to deliver a predetermined volume along a section of the dialysis fluid tubing system, the pressure in the dialysate drain line 130 increases linearly until the predetermined volume has been delivered or should have been delivered, i.e., until the dialysis fluid pump 121 is switched off at time t2.
[0139] There is now a pressure in the dialysate drain line 130 compared to the initial value p A increased pressure with the pressure value p B , which in turn can be determined by the pressure sensor PS4 . From the determined pressure values p A , p B For example, the pressure development Ap can then be determined, here as a simple di f ference Ap B :
[0140] Api = p B ~ PA
[0141] A subsequent evaluation of the determined pressure value p B and / or the determined pressure development Ap, for example, whether an overpressure and in particular an overpressure expected in the dialysate discharge line 130 measured against the first criterion could be built up. For example, this can be done by comparing the final pressure p Bwith a target pressure value psoll or the pressure development Ap with a target pressure development APsoll . Target pressure value psoll or target pressure development APsoll can serve here as an example of a predetermined criterion (also referred to herein as the third criterion). A comparison with this can, for example, provide the result that the dialysis fluid supply line 120 is not blocked, which would be the case, for example, with a closed manual hose clamp, and that it is in fluid communication with the extracorporeal blood circuit 300 in at least one direction. In Fig. 3, the final pressure p B the target pressure value psoll . The pressure development Ap corresponds to the target pressure development APsoll .
[0142] An output of this check result based on the result of this evaluation, for example as a warning about an improperly connected dialysis fluid supply line 120 or a closed hose clamp, may be provided in some embodiments.
[0143] Fig. 4 shows in a highly simplified form a curve 1000' of a pressure profile within the extracorporeal blood circuit 300 and / or within the dialysate drain line 130 during an exemplary embodiment of the method steps M5 and M6 of the method according to the invention of Fig. 1.
[0144] Analogous to Fig. 3, the pressure P, for example in the unit [hPa], is shown on the y-axis, and the time t, for example in the unit seconds [s], is shown on the x-axis. In the example in Fig. 4, the continuous curve 1000' shows the course of the pressure values measured by at least one of the pressure sensors PS1, PS2, PS3 in the extracorporeal blood circuit 300 and / or the course of the pressure values measured by the pressure sensor PS4 in the dialysate drain line 130 over time. Such a pressure build-up can only take place if a functional throttle T_Dia is arranged in the dialysis fluid hose system downstream of the first heating device 123. For comparison, reference is made to the dashed curve 2000', which expresses the absence of a functional throttle T_Dia in the dialysis fluid hose system.
[0145] To increase the pressure as shown in Fig. 4, with the venous tube clamp 61 closed, the blood pump 101 can be actuated at a time t3 in order to deliver a predetermined volume of fluid within at least a portion of the extracorporeal blood circuit 300 to build up a pressure downstream of the blood pump 101. When and as long as the blood pump 101 is pumping, the pressure in the extracorporeal blood circuit 300 and in the dialysate drain line 130 should increase linearly, as is the case in Fig. 4, until the predetermined volume has been delivered or should have been delivered, i.e. until the blood pump 101 is switched off at a time t4.
[0146] After pressure has been built up within the extracorporeal blood circuit 300, the then prevailing pressure is measured by means of one of the pressure sensors PS1, PS2, PS3, PS4 to achieve a pressure value p c and / or a pressure development Ap of the prevailing pressure. The determined pressure value pc and / or the determined pressure development Ap can now be evaluated on the basis of at least one predetermined criterion (also referred to herein as the first predetermined criterion), for example by means of comparison with desired pressure values psoll or a desired pressure development APsoll.
[0147] Alternatively or additionally, in some embodiments, the verification result, referred to herein as the first, is output based on this evaluation.
[0148] For comparison, in the example of Fig. 4, the dashed curve 2000 ' already mentioned above shows the course of the pressure values measured by at least one of the pressure sensors PS1, PS2, PS3 in the extracorporeal blood circuit 300 and / or the course of the pressure values measured by the pressure sensor PS4 in the dialysate outlet line 130 over time when no functional throttle T_Dia is arranged in the dialysis fluid hose system downstream of the first heating device 123.
[0149] It can be clearly seen from the example in Fig. 4 that the gradients of the pressure curves differ significantly, whereby gradients of curves, e.g. in a pressure-time diagram, can be understood as pressure developments Ap in a time interval At: where — the gradient of the pressure curve related to the time interval At with a functioning throttle T_Dia and
[0150] — the gradient of the pressure curve relative to the time interval At when the throttle T_Dia is inoperative (or missing).
[0151] The times t3 and t4 can be after the times tl and t2, as discussed in Fig. 3.
[0152] Fig. 5 shows in a very simplified form another
[0153] Curve 1000' ' of the pressure curve within the extracorporeal blood circuit 300 and / or within the
[0154] Dialysate drain line 130 during the method according to the invention, exemplifying a part of the method of Fig. 1 (method steps M9 to Mil).
[0155] Analogous to Fig. 3 and Fig. 4, the pressure P is shown on the y-axis, for example in the unit [hPa], and the time t is shown on the x-axis, for example in the unit seconds [s].
[0156] In the example of Fig. 5, the continuously displayed curves 1000', 1000'' show the course of the pressure values measured by at least one of the pressure sensors PSI, PS2, PS3 in the extracorporeal blood circuit 300 over time. Curve 1000' may correspond to curve 1000' in Fig. 4 and may have been determined in this way.
[0157] For illustration purposes, the curve 3000 shown as a dash-dot line shows the hypothetical pressure curve in the dialysis fluid supply line 120, in particular between the dialysis fluid pump 121 and the
[0158] Closure mechanism (hereinafter referred to as throttle T_Dia, see Fig. 2) over time. It is assumed here that, if the fluid present in the dialysis fluid supply line 120 is prevented from draining off by means of the throttle T_Dia, and starting immediately after the dialysis fluid pump 121 is started, an immediate increase in the pressure in the dialysis fluid supply line 120 in the section specified above is assumed. The curve 3000 of this pressure curve is based on assumed pressure values, not on measured values, since in the above-specified section of the dialysis fluid supply line 120 between the dialysis fluid pump 121 and the closure mechanism, at least in this embodiment, there are no pressure sensors.
[0159] The curve 1000 ' ' shown with a continuous line, however, is based on concrete measured values of the pressure prevailing in the extracorporeal blood circuit 300 as follows: Starting from the pressure value p prevailing at the time t5, which is preferably later than the above-mentioned times tl to t4, and which is known as pressure value p c measured pressure, the dialysis fluid pump 121 is actuated again. As a result, pressure is further built up within at least one section of the dialysis fluid hose system, in particular in the dialysis fluid supply line 120, in particular between the dialysis fluid pump 121 and the throttle T_Dia.
[0160] If the throttle T_Dia is functioning properly, the pressure value p cin the extracorporeal blood circuit 300, i.e. downstream of the conveying dialysis fluid pump 121 and downstream of the throttle T_Dia, will initially remain constant, as can be seen from curve 1000 ' '. It will only increase when the pressure in the dialysis fluid supply line 120 reaches a preferably known opening pressure p open thr of the throttle T_Dia is reached, since after the associated opening of the throttle T_Dia, fluid will also be pumped downstream and subsequently also present on the blood side. A pressure increase in the extracorporeal blood circuit 300 can be detected (after actuation of the dialysis fluid pump 121 at time t5) by means of an optional, preferably continuous, determination of the pressure prevailing within the extracorporeal blood circuit 300 by means of one of the pressure sensors PS1, PS2, PS3 (from time t6 in Fig. 5). If such an increase in pressure is detected in the extracorporeal blood circuit 300, the dialysis fluid pump 121 can optionally be stopped again (e.g. at time t7 in Fig. 5). In the extracorporeal blood circuit 300, the pressure p reached therein up to then will D hold .
[0161] Subsequently, the pressure value p determined for time t7 can optionally be D, the determined pressure development Ap and / or the question as of which point in time t an increase in the pressure in the extracorporeal blood circuit 300 could be measured, are evaluated using at least one predetermined criterion, also referred to herein as the second predetermined criterion. The predetermined second criterion can, for example, be a temporal duration, a temporal offset or a time delay, also referred to herein as a "delay". The pressure development Ap in the extracorporeal blood circuit 300 can thus be evaluated with regard to the pressure increase and / or the time, i.e. it can, for example, be considered whether and, if so, when a pressure increase occurred and / or how much time has passed between the start of the dialysis fluid pump 121 and a pressure increase in the extracorporeal blood circuit 300.The evaluation can be a comparison, in particular whether the time offset AT lies outside a predetermined time range, in particular whether it is too short or too long compared to a predetermined time period.
[0162] In the context of these steps, it would be advantageous in particular to avoid overlooking an incorrect execution of some or all of the checking steps of the present method, which could occur in particular if the dialysis fluid supply line 120 is accidentally closed or closed, for example by means of a manual hose clamp (not shown).
[0163] An optional output of the verification result (also referred to herein as second verification result) based on the result of the evaluation as explained above is also encompassed by the present invention.
[0164] For example, if the dialysis fluid supply line 120 were closed, a pressure increase in the extracorporeal blood circuit 300 would not occur. If the throttle T_Dia were missing, a pressure increase in the extracorporeal blood circuit 300 would occur with less time delay AT. If the throttle T_Dia were defective, a pressure increase would occur sooner or later than expected.
[0165] Fig. 6 shows an overview of the status of pumps, pressure sensors PS1, PS2, PS3, PS4 used and the state of the hose clamps during individual steps of an optional embodiment of the method according to the invention in tabular form.
[0166] The table shown summarizes the states of the pumps used (active / standstill), the corresponding pressure sensors (preferred, alternative, and ignored) for detecting the pressure, and the state of the hose clamps (open / closed). Reference is made in the table to the reference symbols of the figures and to the numbering of the process steps from Fig. 1.
[0167] The table shows that in the present examples, the pressure sensors PS I upstream of the blood pump are not used to detect pressure values. This may be different in other embodiments, particularly if a short-circuit line is arranged in the extracorporeal blood tubing set.
[0168] Although the measured values of the pressure sensor PS4 in the dialysate drain line are preferably used in the present examples, the measured values of the pre-filter pressure sensor PS2 and / or the optional venous pressure sensor PS3 could alternatively be used for the method according to the invention.
[0169] List of reference symbols
[0170] 25 Anticoagulant addition site
[0171] 50 first line; arterial line section
[0172] 51 Tube clamp, arterial
[0173] 60 second line; venous line section
[0174] 61 Tube clamp, venous
[0175] 100 blood treatment device
[0176] 101 Blood Pump
[0177] 110 Substitute line
[0178] 111 Substitution pump
[0179] 120 Dialysis fluid inlet
[0180] 121 Dialysis fluid pump
[0181] 123 first heating bag
[0182] 125 second heating bag
[0183] 130 Filtrate or dialysate drain line
[0184] 131 Filtrate pump
[0185] 140 venous bladder trap
[0186] 150 control device
[0187] 200 first fluid source (dialysis fluid)
[0188] 210 second fluid source (substitute)
[0189] 300 extracorporeal blood circulation
[0190] 303 Blood filter or dialyzer
[0191] 303a Dialysis fluid chamber
[0192] 303b Blood chamber
[0193] 303c semi-permeable membrane
[0194] 400 Ef f luentbeutel
[0195] 1000 curve; pressure curve
[0196] 1000 ' curve ; pressure curve
[0197] 1000 ' ' curve ; pressure curve
[0198] 2000 ' curve ; pressure curve
[0199] 3000 Curve; hypothetical pressure curve H_Dia first heating device (for dialysis fluid)
[0200] H_Sub second heating device (for substituate)
[0201] Ml to M12 process steps p A to p D Pressure values psoll Target pressure value
[0202] Ap pressure development
[0203] APsoll Target pressure development
[0204] Apx to Ap3 pressure differences PSI arterial pressure sensor (optional)
[0205] PS2 arterial pre-filter pressure sensor (optional)
[0206] PS3 pressure sensor (optional)
[0207] PS4 pressure sensor (optional)
[0208] Popen thr Opening pressure of the throttle tl to t7 times
[0209] T_Dia throttle (in dialysis fluid supply line)
[0210] T_Sub throttle (in substitution line)
[0211] AT time offset; time delay; delay
Claims
Claims 1. A method for checking an equipment status of a blood treatment device (100) relating to a dialysis fluid hose system, comprising the steps of: Providing (Ml) the Blood treatment device (100) with a blood pump (101), a dialysis fluid pump (121), several pressure sensors (PS1, PS2, PS3, PS4), and at least one first Heating device (H_Dia) which has a first receiving section for receiving a first heating bag (123) for heating medical liquid flowing through it; Providing (M2) an extracorporeal blood circuit (300), inserting a section thereof into the blood pump (101) and at least partially filling the extracorporeal bloodstream (300) with fluid; Providing (M3) a dialysis fluid hose system, comprising at least one dialysis fluid supply line (120) with a first heating bag (123) integrated therein and a closure mechanism for closing a flow-through lumen of the dialysis fluid Hose system downstream of the first heating bag (123) and / or at least one device for generating or changing a flow resistance in the dialysis fluid hose system downstream of the first heating bag (123), or consisting thereof; Inserting (M4) the first heating bag (123) into the first receiving section of the first heating device (H_Dia); Building up pressure (M5) within at least a portion of the extracorporeal blood circuit (300) by means of the blood pump (101); Determining (M6) the pressure prevailing after pressure has been built up within the extracorporeal blood circuit (300) by means of one of the pressure sensors (PSI, PS2, PS3, PS4) to achieve a pressure value (p c ) and / or a pressure development (Ap) of the prevailing pressure; Evaluate (M7) the determined pressure value (p c ) and / or the determined pressure development (Ap) based on at least one first predetermined criterion; and Output (M8) an initial review result based on the result of the assessment.
2. The method of claim 1, wherein the method further comprises: Building up (M9) pressure within at least one section of the dialysis fluid hose system by means of the dialysis fluid pump (121); Determining (MIO) the pressure prevailing after pressure has been built up by means of the dialysis fluid pump (121) within the extracorporeal blood circuit (300) by means of one of the pressure sensors (PSI, PS2, PS3, PS4) to achieve a pressure value (p D ) and / or a pressure development (Ap) of the prevailing pressure; Evaluate (Mil) the determined pressure value (p D ) and / or the determined pressure development (Ap) based on at least one second predetermined criterion; and Output (M12) a second review result based on the result of the assessment.
3. The method according to claim 1 or 2, wherein before pressure is built up within at least one section of the extracorporeal blood circuit (300) by means of the blood pump (101) and / or at least one section of the dialysis fluid tubing system by means of the dialysis fluid pump (121), the section is filled with fluid, in particular priming fluid or rinsing fluid.
4. Method according to one of the preceding claims, further comprising the step (M4a): Creating predetermined initial conditions within the extracorporeal blood circuit ( 300 ) before building up pressure within at least a portion of the extracorporeal blood circuit ( 300 ) by means of the blood pump ( 101 ) .
5. Method according to the preceding claim, wherein the creation of predetermined initial conditions comprises or consists of setting a predetermined fluid level in a bubble chamber, a venous chamber or a venous bubble trap (140) of the extracorporeal blood circuit (300).
6. Method according to one of the preceding claims, wherein, by considering the first and / or the second test result, it is determined whether the dialysis fluid hose system has a closure mechanism for closing a flow-through lumen of the dialysis fluid hose system downstream of the first heating bag (123) and / or at least one device for generating or changing a flow resistance downstream of the first heating bag (123). 7 . Method according to one of the preceding claims, wherein before evaluating the determined pressure value (p c) and / or the determined pressure development ( Ap ) and / or before issuing a first verification result based on the result of the evaluation, the following steps are carried out (M4b ): Actuating the dialysis fluid pump ( 121 ) to deliver a predetermined volume along a Section of the dialysis fluid tubing system; Stopping the dialysis fluid pump (121) after the predetermined volume has been delivered or should have been delivered; Determining the pressure prevailing within the dialysis fluid tubing system after the delivery of the predetermined volume by means of one of the pressure sensors ( PS I , PS2 , PS3 , PS4 ) to obtain a pressure value (p B ) and / or a pressure development ( Ap ) of the prevailing pressure; Evaluate the determined pressure value (p B) and / or the determined pressure development ( Ap ) based on at least one third predetermined criterion; and Issue a third review score based on the assessment result.
8. Method according to the preceding claim, wherein, taking into account the third check result, it is determined whether the dialysis fluid hose system is connected to the blood treatment device (100) and / or whether the dialysis fluid hose system is permeable to fluid. 9 . Method according to one of the preceding claims , wherein the method is carried out before the start of a treatment or examination of a patient by means of the blood treatment device ( 100 ) , but preferably after completion of the filling or priming of a upcoming treatment or examination of the patient with the extracorporeal blood circuit (300) connected to the blood treatment device (100) is carried out and completed.
10. Method according to one of the preceding claims, wherein the closure mechanism for closing a flow-through lumen of the dialysis fluid hose system downstream of the first heating bag (123) and / or at least one device for generating or changing a flow resistance in the dialysis fluid hose system downstream of the first heating bag (123) is or comprises a check valve or a throttle (T_Dia).
11. Method according to one of the preceding claims, further comprising issuing an alarm by means of an alarm device, preventing the implementation of a treatment option by means of the blood treatment device (100) and / or stopping the operation of the blood treatment device (100), depending on the first, second and / or third check result.
12. Control device (150) configured to cooperate with a provided blood treatment device (100) with a blood pump (101); a dialysis fluid pump (121), a plurality of pressure sensors (PS1, PS2, PS3, PS4), at least a first Heating device (H_Dia) which has a first receiving section for receiving a first heating bag (123) for heating medical fluid flowing through it; an extracorporeal blood circuit (300) with at least a section of which is inserted into the blood pump (101) and at least partially filled with fluid; and a dialysis fluid hose system, having at least one dialysis fluid supply line (120) with a first heating bag (123) integrated therein and a closure mechanism for closing a flow-through lumen of the dialysis fluid hose system downstream of the first heating bag (123) and / or at least one device for generating or changing a flow resistance in the dialysis fluid hose system downstream of the first heating bag (123), or consisting thereof; to initiate or carry out the method according to one of the preceding claims.
13. Blood treatment device (100) comprising or connected to a blood pump (101); a dialysis fluid pump (121), a plurality of pressure sensors (PS1, PS2, PS3, PS4), at least one first heating device (H_Dia) having a first receiving portion for receiving a first heating bag (123) for heating medical fluid flowing through it; and a control device (150) according to claim 12.
14. The blood treatment device (100) according to claim 13, wherein the control device (150) is further configured to issue an alarm by means of an alarm device, to prohibit a treatment option by means of the blood treatment device (100) and / or to stop the operation of the blood treatment device (100), depending on the first, second and / or third check result.
15. Blood treatment device (100) according to one of claims 13 to 14, designed as a device for treatment by means of dialysis, hemodialysis, hemofiltration, or hemodiafiltration, or as a plasmapheresis device.
16. Digital storage medium, in particular in the form of a floppy disk, CD or DVD or EPROM, with electronically readable control signals, configured to configure a control device to a control device (150) according to claim 12, by means of which the mechanical steps of the method according to one of claims 1 to 11.
17. Computer program product with a program code stored on a machine-readable carrier in order to configure a control device to a control device (150) according to claim 12, by means of which the mechanical steps of the method according to one of claims 1 to 11 can be initiated.
18. Computer program with a program code for configuring a control device to a control device (150) according to claim 12, by means of which the mechanical steps of the method according to one of claims 1 to 11 can be initiated.
Citation Information
Patent Citations
Hose adapter for influencing the pressure inside a hose section during a medical treatment
WO2013135365A2
Extracorporeal blood treatment apparatus and method for checking the connection of a soft bag in an extracorporeal blood treatment apparatus
US20200054816A1
Method for determining sodium clearance of dialyzer
US5716531A