Blood treatment device with ambient temperature variation compensation

Abstract

The present invention relates to a control or regulation device (150) configured to control or regulate the operation of a blood treatment device (100) for treating a patient during a blood treatment period wherein the blood treatment device (100) is connected to an extracorporeal blood circuit (300) and to a blood treatment device, such as a dialyzer (303) or a blood filter. The blood treatment apparatus (100) further comprises a dialysis liquid inlet line (104) and a dialysis liquid outlet line (102), a heating device (162) for heating the dialysis liquid, and one or more temperature sensors (165a, 165b) wherein at least a first temperature sensor (165a) is arranged downstream of the blood treatment device and / or downstream of the dialysis liquid inlet line (104) and at least a second temperature sensor (165b) is arranged downstream of the dialysis liquid outlet line (102). A first temperature value (T1) of a first liquid flowing prior to the dialysis liquid inlet line (104) is determined for determining a second temperature value (T2) of a second liquid flowing prior to the dialysis liquid inlet line (104). Here, the control or regulation device (150) is configured to increase or set the temperature of the dialysis liquid using the heating device (162) on the basis of a first temperature value (T1) determined by the first temperature sensor (165a).

Description

Technical Field

[0001] The present invention relates to a control or regulating device according to claim 1, a blood treatment apparatus according to claim 16, a digital storage medium according to claim 20, a computer program product according to claim 21 and a computer program according to claim 22, or to the corresponding subject matter defined in the respective preambles or general terms of these claims. Background Art

[0002] Blood treatment apparatuses are known in practice in which a treatment liquid is supplied to a patient via a pump, typically via an extracorporeal blood circuit, as in the case of dialysis apparatuses. In blood treatment apparatuses such as dialysis apparatuses, the treatment liquid is additionally or alternatively supplied to, for example, a blood filter through which the blood flows. Because the temperature of the delivered treatment liquid in both cases may affect the temperature of the blood to be returned to the patient, a heating device may be provided to heat or otherwise regulate the temperature of the treatment liquid. Summary of the Invention

[0003] The object of the present invention is to provide another control device or regulating device and another blood treatment apparatus. A digital storage medium, a computer program product and a computer program are also provided.

[0004] The object according to the invention is achieved by a control or regulating device having the features of claim 1 and / or a blood treatment apparatus having the features of claim 16. Furthermore, it is achieved by a digital storage medium having the features of claim 20, a computer program product having the features of claim 21 and / or a computer program having the features of claim 22.

[0005] The invention relates to a control or regulating device configured to control or regulate the operation of a blood treatment apparatus for treating a patient during a blood treatment session, wherein the blood treatment apparatus is connected to an extracorporeal blood circuit and a blood treatment device, such as a dialyzer or a blood filter.

[0006] The blood treatment apparatus further comprises a dialysis fluid inlet line configured to supply dialysis fluid to the blood treatment device during a blood treatment session, and a dialysis fluid outlet line configured to discharge dialysis fluid (ie, spent dialysis fluid) from the blood treatment device during a blood treatment session.

[0007] The blood treatment apparatus further comprises a heating device for heating the dialysis fluid before or during a blood treatment session.

[0008] The blood treatment apparatus further comprises one or more temperature sensors. These sensors may be thermometers or devices capable of estimating temperature.

[0009] At least a first of these temperature sensors is arranged downstream of the blood treatment device and / or downstream of the dialysis fluid inlet line for determining a first temperature value of a first fluid previously flowing along the dialysis fluid inlet line to the blood treatment device.

[0010] In this case, the control or regulating device is configured to increase or set the temperature of the dialysis fluid by means of the heating device on the basis of the first temperature value determined by the first temperature sensor.

[0011] The present invention proposes a blood treatment apparatus which is equipped for use with an extracorporeal blood circuit and a blood treatment device, such as a dialyzer or a blood filter, for treating a patient's blood during a blood treatment session.

[0012] The blood treatment apparatus according to the invention comprises at least one receptacle for releasably receiving at least a part of the extracorporeal blood circuit on the blood treatment apparatus.

[0013] The blood treatment apparatus according to the invention further comprises at least one receptacle for releasably receiving at least a part of the blood treatment device on the blood treatment apparatus.

[0014] The blood treatment apparatus according to the present invention further comprises a dialysis fluid inlet line and a dialysis fluid outlet line, wherein the dialysis fluid inlet line is configured to supply dialysis fluid to the blood treatment device during a blood treatment session, and the dialysis fluid outlet line is configured to discharge dialysis fluid (i.e., spent dialysis fluid) from the blood treatment device during a blood treatment session.

[0015] The blood treatment apparatus further comprises one or more temperature sensors, which may be thermometers or devices for estimating temperature. At least a first temperature sensor of these temperature sensors is arranged downstream of the blood treatment apparatus and / or downstream of the dialysis fluid inlet line and is configured to determine a first temperature value of a first liquid flowing through or remaining in the dialysis fluid inlet line.

[0016] The blood treatment apparatus according to the invention further comprises a heating device for heating the dialysis fluid before or during a blood treatment session.

[0017] The blood treatment apparatus according to the invention further comprises a control device or regulating device according to the invention, by means of which the operation of the blood treatment apparatus can be controlled or regulated.

[0018] According to the invention, a digital storage medium, in particular a non-volatile storage medium, in particular in the form of a machine-readable medium, in particular in the form of a floppy disk, memory card, CD, DVD, EPROM, ferroelectric memory (FRAM) or solid-state drive (SSD), in particular having electronically or optically readable control signals, can interact with a programmable computer system to reprogram a conventional control or regulating device into a control or regulating device according to the invention. Alternatively or additionally, a conventional blood treatment device can be reprogrammed into a blood treatment device according to the invention.

[0019] The computer program product according to the present invention comprises a volatile or transient program code, a program code stored on a machine-readable medium, or a signal wave, whereby, when the computer program product is run on a computer, a conventional control or regulating device can be reprogrammed into a control or regulating device according to the present invention. Alternatively or additionally, a conventional blood treatment apparatus can be reprogrammed into a blood treatment apparatus according to the present invention.

[0020] According to the present invention, a computer program product may be understood as, for example, a computer program stored on a carrier, an embedded system as an integrated system with a computer program (e.g. an electronic device with a computer program), a computer-implemented computer program network (e.g. a client / server system, a cloud computing system, etc.), or a computer on which a computer program is loaded, run, stored, executed or developed.

[0021] As used herein, the term "machine-readable carrier" refers, in certain embodiments of the present invention, to a carrier containing data or information that can be interpreted by software and / or hardware. The carrier can be a data carrier such as a floppy disk, CD, DVD, USB flash drive, flash memory card, SD card, or the like, as well as any other memory or storage medium mentioned herein.

[0022] The computer program according to the present invention comprises program code which, when executed on a computer, reprograms a conventional control or regulating device into a control or regulating device according to the present invention. Alternatively or additionally, a conventional blood treatment apparatus can be reprogrammed into a blood treatment apparatus according to the present invention.

[0023] Unless a person skilled in the art considers that a specific combination is technically infeasible, an embodiment according to the present invention may include any combination of one, more or all of the features mentioned below.

[0024] In all the above and following expressions, the use of expressions such as "may be" or "may have" should be understood as being synonymous with expressions such as "preferably is" or "preferably has", respectively, and is intended to illustrate embodiments according to the present invention.

[0025] Whenever a numerical word is mentioned herein, a person skilled in the art should regard or understand it as an indication of a lower limit of the numerical value. Therefore, unless this leads to an obvious contradiction for a person skilled in the art, a person skilled in the art should understand, for example, "one (kind)" to include "at least one (kind)". The present invention also encompasses another interpretation, that is, when a person skilled in the art considers it technically obvious that it is feasible, a numerical word (such as "one (kind)") can also alternatively mean "exactly one (kind)". Both of these understandings are included in the scope of the present invention and apply to all numerical words used herein.

[0026] Whenever reference is made herein to spatial information such as "top," "bottom," "left," or "right," those skilled in the art will understand these to be spatial references with reference to the orientation of the accompanying drawings and / or the orientation during use. "Bottom" is closer to the center of the Earth or the lower edge of the drawing than "top."

[0027] When reference is made herein to "determining" (particularly determination of data and / or temperature values), it may mean or include checking for existence or absence, measuring, setting, detecting, recording, collecting, evaluating, processing, comparing, estimating, rating, inferring, calculating, obtaining, achieving or realizing, and / or identifying.

[0028] Advantageous developments of the invention are each the subject matter of the dependent claims and exemplary embodiments.

[0029] Whenever an embodiment is mentioned herein, this embodiment represents an exemplary embodiment according to the present invention and should not be construed as limiting.

[0030] When it is disclosed herein that the subject matter according to the present invention includes one or more features in a particular embodiment, it is also disclosed that the subject matter according to the present invention explicitly does not include the feature or features in other embodiments (e.g., in the form of a disclaimer). Therefore, for each embodiment mentioned herein, the opposite embodiment (e.g., expressed in a negative form) is also disclosed.

[0031] When reference is made herein to "programming" or "configuration," in some embodiments these terms are used interchangeably.

[0032] When referring to signal communication or a communication connection between two components herein, it is understood that the connection exists during use. It is also understood that there is a provision for such signal communication (whether achieved by wired, wireless or other means), for example, by coupling the two components (such as pairing, etc.).

[0033] Pairing is a process carried out in connection with computer networks to establish an initial link between computer units for communication. The most well-known example is establishing a Bluetooth connection, which allows various devices (such as smartphones and headphones) to connect to each other. Pairing is sometimes also called bonding.

[0034] The control device or regulating device may cause all or substantially all method steps to be carried out. The method according to the invention may be carried out substantially or completely by the control device. It may be carried out partially by the control device, in particular those steps which do not require or involve human intervention, and / or the control device may carry out preparatory work. The control device may function solely as a control device or as a regulating device.

[0035] In a number of embodiments, the control device or regulating device is present in or on the blood treatment apparatus, for example in a common housing of the blood treatment apparatus together with other components or devices of the blood treatment apparatus.

[0036] In some embodiments, the control or regulation device according to the invention is configured to increase or set the temperature by the heating device additionally based on a second temperature value. The second temperature value can be or has been determined by a second temperature sensor of a plurality of temperature sensors for the first liquid upstream of the blood treatment device and / or upstream of the dialysate outlet line.

[0037] In various embodiments, the first temperature value and / or the second temperature value is determined or has been determined before the start of the blood treatment session.

[0038] The first temperature value and / or the second temperature value can be stored in the control or regulating device or in a memory device adapted or provided for this purpose.

[0039] In some embodiments, the first temperature value and / or the second temperature value is determined or has been determined during a blood treatment session.

[0040] In various embodiments, the first temperature value or the second temperature value, respectively, is determined or has been determined when the dialysis fluid inlet line and the dialysis fluid outlet line are in fluid communication with each other, eg via a short-circuit line which excludes or bypasses the blood treatment device.

[0041] In some embodiments, the first temperature value and / or the second temperature value is determined or has been determined when the dialysis fluid inlet line and the dialysis fluid outlet line are not arranged to exclude or bypass the blood treatment device but are respectively connected to the blood treatment apparatus, e.g. in a fluidically connected manner.

[0042] In various embodiments of the control or regulating device according to the present invention, when determining the first temperature value and / or the second temperature value, or for determining the first temperature value and / or the second temperature value, no two different liquids flow through the blood treatment device or are present in the blood treatment device. In particular, no blood as the second liquid flows or is present in the blood treatment device.

[0043] In some embodiments of the control or regulating device, a difference between a first temperature value of the first liquid and a setpoint value therefor for this liquid is determined.

[0044] In several embodiments of the control device or regulating device, it is configured to calculate a calculated temperature value based on the first temperature value and the second temperature value of the first liquid, so as to determine the difference between the calculated temperature value of the blood treatment device and the temperature set value there, and based on the difference between the calculated temperature value at the blood treatment device and the set value for the blood treatment device, cause the heating device to increase or set the dialysis liquid temperature.

[0045] In some embodiments, the user can input, for example, a set temperature for the dialyzer temperature value and / or a set temperature for the first temperature sensor temperature value via an input interface of the blood treatment apparatus. The set temperature for the dialyzer temperature value is required for determining the difference between the dialyzer temperature value and the set temperature, and the set temperature for the first temperature sensor temperature value is required for determining the difference between the measured first temperature value and the set temperature at the first temperature sensor. Alternatively, these set values ​​are stored in a storage device provided for this purpose, and the control device or the regulating device can call them from the storage device.

[0046] In some embodiments, the calculated temperature value at the blood treatment apparatus is determined or calculated or has been determined or calculated based on the first temperature value and / or the second temperature value and a temperature coefficient determined for the dialysis fluid inlet line or for the first line segment (in particular the first line segment extending outside the blood treatment apparatus, in particular for its length) and / or for the dialysis fluid outlet line or for the second line segment (in particular the second line segment extending outside the blood treatment apparatus, in particular for its length).

[0047] Calculating the calculated temperature value at the blood treatment device or dialyzer provides an estimate of the actual temperature of the first liquid as it flows through the blood treatment device. This can be used to determine the difference between the estimated temperature at the blood treatment device and its setpoint therein. According to the present invention, this difference is used to cause a heating device to increase or set the dialysate fluid temperature based on the difference between the calculated temperature value and its setpoint.

[0048] Here, in one embodiment, the calculated temperature value T in the dialyzer rech The following formula applies:

[0049] T rech =T2-L1*T k

[0050] or

[0051] T rech =T1+L2*T k

[0052] and the temperature at the first temperature sensor

[0053] T1=T2-((L1+L2)*T k )

[0054] In various embodiments, the control device or the regulating device is configured to determine the temperature coefficient T k .

[0055] If it is assumed that there is a linear temperature drop over the respective pipeline lengths L1, L2 of the pipeline segments, a temperature coefficient T in [°C / m] can be defined for this purpose. k , for example:

[0056]

[0057] The meaning of each parameter is:

[0058] T1: The first temperature value measured by the first temperature sensor downstream of the dialyzer

[0059] T2: The second temperature value measured by the second temperature sensor upstream of the dialyzer

[0060] L1: Length of the line section preferably located outside the blood treatment apparatus and upstream of the dialyzer

[0061] L2: Length of the line segment preferably located outside the blood treatment apparatus and downstream of the dialyzer

[0062] In some embodiments, the control device or regulating device is configured to determine a temperature coefficient associated with one, two or more (in particular preset) flow rates of the first liquid flowing into or through the blood treatment device. Alternatively, in the case of an exclusion or bypass blood treatment device, the temperature coefficient is determined or has been determined for one, two or more (in particular preset) flow rates of the first liquid in a short circuit (e.g., a short circuit line) between the dialysis fluid inlet line and the dialysis fluid outlet line.

[0063] If a linear relationship between temperature drop and flow rate is assumed, then for a reference flow rate of 500 ml / min, the following formula applies:

[0064]

[0065] In some embodiments, the above calculation assumes that the ambient temperature value T Umg The impact is uniform.

[0066] In some embodiments, the control device or regulating device according to the invention is configured to increase or decrease the temperature of the dialysis fluid heated using the heating device during or before a blood treatment session by a first temperature value or a difference between a calculated temperature value and the corresponding temperature setpoints at these points.

[0067] In several exemplary embodiments of the control or regulating device, only a first temperature value downstream of the blood treatment device is determined.

[0068] In some embodiments, the control device or regulating device is configured to further take into account a determined ambient temperature value when increasing or setting the temperature of the dialysis fluid heated by the heating device during or before the blood treatment period. The ambient temperature value can be determined or already determined, for example, by an ambient temperature sensor (e.g., a temperature sensor of the blood treatment device).

[0069] In various embodiments, the blood treatment apparatus according to the invention further comprises a second temperature sensor among the plurality of temperature sensors for determining a second temperature value of the first liquid upstream of the blood treatment device or upstream of the dialysate outlet line.

[0070] In some embodiments, the blood treatment apparatus further comprises an ambient temperature sensor or is connected to an ambient temperature sensor. The ambient temperature sensor is adapted and / or configured to determine an ambient temperature value of the blood treatment apparatus.

[0071] In some embodiments, the ambient temperature sensor communicates with the control device or the regulating device and can transmit the measured ambient temperature value to the control device or the regulating device. Alternatively, the control device or the regulating device can be used to retrieve the temperature value from the ambient temperature sensor.

[0072] In several embodiments, the blood treatment apparatus is embodied as a dialysis apparatus, a hemodialysis apparatus, a hemofiltration apparatus or a hemodiafiltration apparatus, in particular as an apparatus for acute renal replacement therapy, chronic renal replacement therapy or continuous renal replacement therapy (CKRT).

[0073] In some embodiments, the present invention is not limited to the use of blood treatment equipment using a dialyzer for blood treatment. Its use in other medical technology fields not for treating patients with impaired renal function is also within the scope of the present invention.

[0074] In some embodiments, other device internal effects, particularly temperature effects, are included in the calculations as described herein, while in other embodiments they are not considered. k Therefore, a series of temperature coefficients T can be determined for different preset environmental conditions, especially for the ambient temperature. k , and optionally store it in, for example, a storage device.

[0075] In various embodiments, the values, setpoints, and coefficients disclosed herein may optionally be determined or calculated by a control or regulating device within the scope of the present disclosure, for example, by a corresponding computing device included in or connected to the control or regulating device. Alternatively, they may be retrieved from a storage device by the control or regulating device. These values, setpoints, and coefficients may be stored in the storage device after being initially determined by the control or regulating device or computing device in a previous step or at an earlier point in time.

[0076] When method steps are mentioned herein, it is provided in many embodiments that these steps occur before or after treatment of the patient, for example when the patient is not connected to the device, for example via an extracorporeal blood circuit, or when treatment has not yet started or has ended.

[0077] In some embodiments, the patient's body temperature and / or a temperature associated therewith is not measured or determined and / or the temperature sensor is not arranged for this purpose. In various embodiments, body temperature is not included in the calculations or determinations performed or initiated by the control device or regulating device or other components, nor is it included in the control.

[0078] In various embodiments, the control device or regulating device does not take into account the patient's body temperature and / or temperatures associated therewith when or in order to regulate or increase the temperature of the dialysis fluid using the heating device.

[0079] In some embodiments, variables that are characteristic of the heat transfer through the dialyzer are not taken into account in calculations or determinations performed or initiated by the control device or regulating device or other component, or in the control.

[0080] Some or all embodiments according to the present invention may include one, several or all of the advantages mentioned above and / or below.

[0081] One advantage of the present invention may be that the heating power of the heating device is controlled based on temperature, thereby ensuring that the temperature at a predetermined location does not exceed a maximum temperature and / or does not fall below a set temperature. This eliminates the need for adjusting the delivery rate of a pump for delivering the treatment liquid to these temperature values, and protects the patient from the effects of using a treatment liquid at an inappropriate temperature.

[0082] According to the invention, the temperature at the temperature sensor or the heat loss of the process liquid between the first and second temperature sensor can be determined by simple means and is then known, so that temperature differences can advantageously be detected and the heating device adjusted accordingly.

[0083] A further advantage of the invention may be that existing systems can be easily retrofitted by means of a software update, since existing sensors of the blood treatment apparatus and its control or regulation devices can be utilized. BRIEF DESCRIPTION OF THE DRAWINGS

[0084] Hereinafter, the present invention will be described by way of example only with reference to the accompanying drawings. In the drawings, the same reference numerals represent the same or similar components. In the drawings:

[0085] Figure 1 A schematic simplified diagram shows a fluid pipeline diagram of a blood treatment apparatus according to the present invention in a first embodiment;

[0086] Figure 2 Shown Figure 1 a portion of a fluid line diagram of a blood treatment apparatus, wherein a short-circuit line connects a dialysis fluid inlet line and a dialysis fluid outlet line to each other instead of the blood treatment apparatus; and

[0087] Figure 3 The control or regulating device according to the invention is shown schematically and in a simplified manner with a temperature data flow. DETAILED DESCRIPTION

[0088] Figure 1 FIG. 1 shows a fluid pipeline diagram of a blood treatment apparatus 100 according to the present invention in a first embodiment. Figure 1 In the figures, the blood treatment apparatus is represented only by individual components which are partially highly schematically simplified.

[0089] The blood treatment apparatus 100 shown in the figure is in an at least partially assembled state of use, connected to an extracorporeal blood circuit 300 which can be connected via a double needle access to the vascular system of a patient, not shown, for treatment, or as Figure 1 As shown, the extracorporeal blood circuit 300 is connected via a single needle access when an additional Y-connector (labeled Y) is used, wherein the extracorporeal blood circuit 300 is optionally not part of the blood treatment device 100, but is part of the blood treatment device in other embodiments. The blood circuit 300 can be present, optionally partially present, in or on the blood cartridge.

[0090] In the event of a need for control or regulation, the pumps, actuators and / or valves in the region of the blood circuit 300 are each connected in signal communication with the blood treatment apparatus 100 according to the invention or a control or regulation device 150 contained therein.

[0091] The blood circuit 300 includes (or is connected to) an arterial patient line clamp 302 and an arterial connection needle ( ) of an arterial segment, an arterial patient line, a blood withdrawal line, or a first line 301. Figure 1 not shown).

[0092] The blood circuit 300 also includes (or is connected to) a venous patient line clamp 306 and a venous connection needle ( Figure 1 not shown).

[0093] A blood pump 101 is provided in or at the first line 301 and an optional replacement fluid pump 111 is connected to eg the dialysis fluid inlet line 104 for delivering fresh dialysate (replacement fluid) filtered in the filtration step (filter F2).

[0094] The optional replacement fluid line 105 can be fluidically connected to, for example, the dialysis liquid inlet line 104. With the help of the replacement fluid pump 111, the replacement fluid can be introduced into a line segment, for example, the arterial line segment 301 or the venous line segment 305 of the blood circuit 300 (here between the blood chamber 303b of the blood filter 303 and the venous air separation chamber or venous blood collector 329), by pre-dilution (via the optional pre-dilution valve 107) or post-dilution (via the optional post-dilution valve 109) via the optional associated line 107a or 109a.

[0095] The blood filter 303 comprises a blood chamber 303b connected to an arterial line segment 301 and a venous line segment 305. The dialysis fluid chamber 303a of the blood filter 303 is connected to a dialysis fluid inlet line 104 leading to the dialysis fluid chamber 303a and to a dialysis fluid outlet line 102 leading the dialysis fluid (i.e., spent dialysis fluid) out of the dialysis fluid chamber 303a. To this end, suitable connectors 104a, 102a on the dialysis fluid inlet line 104 or the dialysis fluid outlet line 102 and the dialysis fluid ports 304a, 304b of the blood filter 303 are connectable to one another, in particular releasably connectable.

[0096] The dialysis fluid chamber 303a and the blood chamber 303b are separated from each other by a substantially semipermeable membrane 303c. The membrane forms a connection between the blood side (with the extracorporeal blood circuit 300) and the machine side (with the dialysis fluid circuit or the dialysate circuit, Figure 1 The separation between the middle membrane 303c is shown on the left).

[0097] Figure 1 The arrangement includes optional detectors 315 for detecting air and / or blood. Figure 1 The arrangement structure can optionally be Figure 1 One or two pressure sensors are also included at the locations shown: PS1 (located upstream of the blood pump 101) and PS2 (located downstream of the blood pump 101 to measure the pressure upstream of the blood filter 303 ("before the blood filter"). Other pressure sensors may also be provided, such as a pressure sensor PS3 downstream of the venous bubble collector 329.

[0098] exist Figure 1 In the embodiment of the present invention, the optional single needle chamber 317 is used as a buffer container and / or compensation reservoir in a single needle operation, when only one of the two blood lines 301, 305 is used to connect the patient to the extracorporeal blood circuit 300.

[0099] Optionally, an addition site 325 for heparin or other (especially local) anticoagulants may be provided.

[0100] exist Figure 1 On the left, an optional mixing device 163 is shown, which provides a predetermined mixture of the respective solutions from container A (for the A concentrate supplied by the concentrate supply device 166) and container B (for the B concentrate supplied by the concentrate supply device 168) for use in the blood treatment apparatus 100. The solution contains water from a water source 155 (online, for example, as reverse osmosis water or from a bag), which is heated, for example, in a heating device 162.

[0101] An optional pump 171 (which may be referred to as a concentrate pump or sodium pump) is fluidly connected to the mixing device 163 and fluidly connected to a sodium source (such as container A), and / or delivers from it. An optional pump 173 associated with container B (e.g., for bicarbonate) can also be seen.

[0102] also, Figure 1 A discharge device 153 for the effluent is shown. An optional heat exchanger 157 and an optional first flow pump 159 suitable for degassing complete the arrangement shown.

[0103] An optional pressure sensor PS4 may be provided downstream of the water side of the blood filter 303 , preferably upstream of the optional ultrafiltration pump 131 in the dialysate outlet line 102 , for measuring the filtrate pressure or membrane pressure of the blood filter 303 .

[0104] The ultrafiltration pump 131 provides a means for removing a precise volume of liquid from the balancing circuit as specified by the user and / or by the control or regulating device 150 .

[0105] Blood exiting the blood filter 303 flows through an optional venous bubble trap 329, which may contain a degasser 318 and may be in fluid communication with a pressure sensor PS3.

[0106] Figure 1 The exemplary arrangement shown comprises a control or regulating device 150 according to the invention. The control or regulating device 150 according to the invention can be connected to any of the components mentioned herein (in particular the blood pump 101) via a wired or wireless signal connection to control or regulate the blood treatment apparatus 100.

[0107] By using a device for online mixing of the dialysis fluid, the sodium content of the dialysis fluid controlled by the control or regulation device 150 can be varied within a certain range. For this purpose, the measured values ​​determined by the conductivity sensors 163a, 163b can be particularly taken into account. If it is necessary or desirable to adjust the sodium content (sodium concentration) of the dialysis fluid or the sodium content of the replacement fluid, this can be achieved by adjusting the delivery rate of the sodium pump 171.

[0108] Furthermore, the treatment apparatus 100 includes a device for delivering fresh dialysis fluid and dialysate. An optional first valve V24 may be provided between the first flow pump 159 and the blood filter 303 to open or close the inlet flow of the blood filter 303. An optional second flow pump 169 is provided to deliver the dialysate to the drain 153, for example, downstream of the blood filter 303. A second valve V25 may be provided between the blood filter 303 and the second flow pump 169 to open or close the outlet flow.

[0109] Furthermore, the blood treatment apparatus 100 optionally comprises a device 161 for balancing the machine-side flows into and out of the dialyzer 303. The balancing device 161 is preferably arranged in a line section between the first flow pump 159 and the second flow pump 169.

[0110] Sensors such as optional conductivity sensors 163a, 163b are used to determine conductivity (which in some embodiments is temperature compensated) and fluid flow upstream and downstream of the dialyzer 303.

[0111] Temperature sensors, including a first temperature sensor 165a and / or a second temperature sensor 165b, may be provided individually or in groups. The temperature values ​​they provide may be used to determine temperature-compensated conductivity during patient treatment, to determine at least one temperature value of the dialysate (downstream of the dialyzer 303) and / or at least one temperature value of the dialysis fluid (upstream of the dialyzer 303) during blood treatment, or, according to the present invention, to determine at least a first temperature value T1 of the fluid flowing downstream of the dialyzer and out of the dialyzer (this fluid may be referred to as dialysate during blood treatment, and this term is also used herein) and / or at least a second temperature value T2 of the fluid flowing upstream of the dialyzer and into the dialyzer (this fluid may be referred to as dialysis fluid during blood treatment, and this term is also used herein).

[0112] Optionally, a leakage sensor 167 is provided. It may also be provided at other locations.

[0113] In addition to the flow pump, for example, referenced at 169 , other flow pumps may be provided in addition or as an alternative.

[0114] Figure 1The optional valves are marked with V; the bypass valve is marked with VB.

[0115] A pressure sensor PS5 may be provided for measuring the pressure in the dialysis fluid inlet line 104 .

[0116] In various embodiments, the control or regulation device 150 determines the electrolyte balance and / or fluid balance based on the measurements of the aforementioned optional sensors.

[0117] Filters F1 and F2 may be provided, connected in series.

[0118] Even when impure water is used, the filter F1 is used here, by way of example, to generate a sufficiently pure dialysis fluid via the mixing device 163 , which then flows through the blood filter 303 , for example using the countercurrent principle.

[0119] The filter F2 is used here, for example, to generate a sterile or fully filtered replacement fluid from the sufficiently pure dialysis fluid leaving the first filter F1 by filtering out pyrogen substances, for example. This replacement fluid can then be safely added to the patient's extracorporeal bloodstream and ultimately enter the patient's body.

[0120] The optional ambient temperature sensor 165c may be a part of the blood treatment device 100 and may communicate with the control device or the regulating device 150 to determine the ambient temperature value T Umg (See Figure 3 The control device or regulating device 150 may be configured to further consider the determined ambient temperature value T when increasing or setting the temperature. Umg .

[0121] The ambient temperature sensor 165 c may also be provided separately from the blood treatment apparatus 100 , but still be in signal communication with the control device or regulating device 150 thereof.

[0122] although Figure 1 The blood treatment apparatus 100 is optionally shown as a hemo(dia)filtration apparatus, but the present invention also covers hemodialysis apparatuses, although this is not specifically shown in the figures.

[0123] Figure 1 The arrows shown in the Figure 1 The flow direction in .

[0124] Figure 2 Shown Figure 1 FIG2 shows a portion of a fluid line diagram of a blood treatment apparatus 100, in which a short-circuit line 350 is used to connect the dialysis fluid inlet line 104 and the dialysis fluid outlet line 102 instead of the blood treatment apparatus 303, which is equivalent to bypassing the blood filter 303. Such a short-circuit can be used, for example, to first check the functionality of all relevant components of the blood treatment apparatus 100 before blood treatment.

[0125] Reference About Figure 1 Description.

[0126] exist Figure 2 In the example of FIG, the dialyzer or blood filter 303 and the extracorporeal blood circuit 300 and its pumps, actuators and / or valves are in an unassembled state and are therefore shown separately from the hydraulic system of the blood treatment apparatus 100 .

[0127] The double-bar line shows the housing wall 360 of the blood treatment apparatus 100. According to the present invention, it is assumed that the temperature of the dialysis fluid or dialysate inside the blood treatment apparatus 100 (i.e., on the left side of the housing wall 360) remains constant, while the dialysis fluid or dialysate flows along the outside of the blood treatment apparatus 100 (i.e., Figure 2 The tubular lines or line segments extending to the right of the housing wall 360 (e.g., the right side of the housing wall 360) and having a defined length L1 or L2 are exposed to the ambient temperature. The ambient temperature may affect the dialysis fluid or its temperature variations. In practice, the temperature of the dialysis fluid within the treatment device 100 (i.e., the fluid flowing toward or into the dialyzer) will naturally vary, but such variations are minimal and negligible for purposes of the present invention.

[0128] In some embodiments, the blood treatment apparatus 100 is calibrated. For this purpose, a predetermined set flow rate through the dialyzer 303 may optionally be specified, but in any case a predetermined set temperature T of the dialysis fluid or the dialysate temperature at or through the dialyzer 303 is set. D_soll The set temperature may be stored in a storage device for the control device or regulating device 150 or may be input by a user, for example, on the blood treatment apparatus 100 .

[0129] After the startup phase, for example, a first temperature T1 (here determined by the first temperature sensor 165a in the dialysate outlet line 102) and / or a second temperature T2 (here determined by the second temperature sensor 165b in the dialysate inlet line 104) can be determined (e.g. measured). The temperature difference T2-T1 reflects the ambient conditions, in particular the ambient temperature value T Umg Effects on the dialysis fluid or the temperature of the dialysate.

[0130] exist Figure 2 In the example of FIG, calibration is performed without the dialyzer 303. In some embodiments, calibration can also be performed with the dialyzer 303, but is preferably performed without the patient because the patient's blood temperature can distort the measurement results.

[0131] The calibration described above using the short-circuited line 350 is the fastest and safest from a risk perspective, since in this case only the radiation characteristics of the tube are included in the measurement.

[0132] The measurement is most accurate if the dialyzer 303 is also connected, since the radiation characteristics of the dialyzer 303 are now also compensated for. This means additional work during the preparation phase, but is also within the scope of the invention.

[0133] Figure 3 A simplified schematic representation of a control or regulating device 150 according to the invention is shown with a temperature data flow.

[0134] Continuous arrows show the flow of dialysis fluid along the heating device 162, the second temperature sensor 165b, through the dialyzer 303, or the flow of the produced dialysate to the first temperature sensor 165a.

[0135] exist Figure 3 In the example shown in FIG. 1 , the dashed arrow indicates a determined temperature.

[0136] To determine the temperature value T rech The set temperature T associated with or required at the dialyzer 303 D_soll The difference between the first temperature value T1 and the set temperature T at the first temperature sensor 165a is required and / or used to determine the first temperature value T1 and the set temperature T at the first temperature sensor 165a. 1_soll The difference between the desired set temperature T D_soll 、T 1_soll , input by the user, or stored in a storage device 151 provided for this purpose, from which the control device or regulating device 150 can call it.

[0137] exist Figure 3 In the example, in addition to the components of the blood treatment apparatus 100, the control device or regulating device 150 also communicates signals with an optionally provided ambient temperature sensor 165c, which is suitable for determining the ambient temperature value T of the blood treatment apparatus 100. Umg , and transmits this value to the control device or regulating device 150. Alternatively, the control device or regulating device 150 can retrieve this temperature from the ambient temperature sensor 165c.

[0138] Likewise, if two temperature sensors 165 a and 165 b are present or are required to determine temperature values ​​T1 , T2 (see previous figures), they are in direct or indirect signal communication with the control or regulating device 150 .

[0139] exist Figure 3 In the example of FIG. 1 , the control or regulating device 150 is designed and configured to calculate a calculated temperature value T at the dialyzer 303 . rech This can be based on the first temperature value T1 and / or the second temperature value T2 of the first liquid, respectively, and also on a temperature coefficient.

[0140] The calculated temperature value T at the blood treatment device or dialyzer 303 rech The calculation of provides an estimate of the actual temperature of the first liquid when it flows through the blood treatment device. It is known that the estimated value is used to determine the estimated temperature at the blood treatment device and its set value T here. D_soll The difference is used to calculate the temperature value T rech With the set value T D_soll The difference between the values ​​of 1 and 2 prompts the heating device 162 to increase or set the dialysis fluid temperature.

[0141] In this example, the ambient temperature value T Umg The impact should be uniform.

[0142] If it is assumed that there is a linear temperature drop over the respective pipeline lengths L1, L2 of the individual pipeline sections, the temperature coefficient T in [°C / m] can be determined for this purpose. k , for example:

[0143]

[0144] The meaning of each parameter is:

[0145] T1: the first temperature value measured by the first temperature sensor 165a downstream of the dialyzer 303

[0146] T2: The second temperature value measured by the second temperature sensor 165b upstream of the dialyzer 303

[0147] L1: Length of the line segment preferably located outside the blood treatment apparatus 100 and upstream of the dialyzer 303

[0148] L2: Length of the line segment preferably located outside the blood treatment apparatus 100 and downstream of the dialyzer 303

[0149] If a linear relationship between temperature drop and flow rate is assumed, then for a reference flow rate of 500 ml / min, the following formula applies:

[0150]

[0151] Using the above formula, the control device or the regulating device 150 can calculate the temperature coefficient T k , and by means of or based on this coefficient, it is calculated how many degrees the temperature of the dialysis fluid currently reached by the heating device 162 must be adjusted to compensate for the influence of the ambient temperature. This may result in a reduction or increase in the heating power.

[0152] Here, in one embodiment, the calculated temperature value T in the dialyzer 303 rech The following formula applies:

[0153] Trech =T2-L1*T k

[0154] or

[0155] T rec =T1+L2*T k

[0156] And the temperature at the first temperature sensor 165a:

[0157] T1=T2-((L1+L2)*T k )

[0158] For example, if the set temperature of the dialyzer 303, i.e. the “desired temperature” T D_soll =37°C, and if the temperature value T2 measured by the second temperature sensor 165b upstream of the blood treatment unit is 37°C, and the temperature losses on the line segments L1 and L2 (here assumed to be equal) are both 1°C, since the first temperature value T1 measured by the first temperature sensor 165a is 35°C, the calculated temperature value T of the dialyzer 303 is rech is 36℃.

[0159] To compensate T rech With T D_soll The difference between the two values ​​is required to cause the heating device 162 to further heat the dialysis fluid by the difference so that the temperature in the dialyzer 303 reaches the desired 37° C. The control device or regulating device 150 can control or regulate the heating device 162 accordingly through programming.

[0160] However, Figure 3 Another embodiment is disclosed in the example of the invention, wherein the control device or regulating device 150 is configured to determine a first temperature value T1 of the first liquid through the first temperature sensor 165a to determine the difference between the measured temperature value T1 and the set temperature or desired temperature set value T 1_soll The difference between the first temperature value T1 and the set value T 1_soll The difference between the first temperature value T1 and the set value T2 prompts the heating device 162 to increase or set the dialysis liquid temperature. This can be achieved by adjusting: after the heating device 162 changes the heating power, the first temperature value T1 is determined again and compared with the set value T 1_soll Compare, and so on. In this process, it is not necessary to consider the ambient temperature value T Umg and a second temperature value T2.

[0161] As can be seen from the above description, the device internal effects on temperature (e.g., the device internal effects that affect the dialysis fluid after it flows through the second temperature sensor 165b) are ignored. Initially, this is not inappropriate. However, in embodiments other than the embodiments discussed above, such device internal effects may also be taken into account. This can be done, for example, when determining the temperature coefficient T k When carried out.

[0162] The values, setpoints, coefficients, etc. disclosed herein may optionally be determined or calculated by the control device or regulating device 150 within the scope of the above disclosure, for example, by a corresponding computing device included in or connected to the control device or regulating device 150. Alternatively, the control device or regulating device 150 may retrieve these values, setpoints, coefficients, etc., respectively, from the storage device 151. These values, setpoints, coefficients, etc. may be stored in the storage device 151 after being first determined by the control device or regulating device 150 or the computing device in a previous step or at an earlier point in time.

[0163] Although the present invention is described herein with emphasis on a blood treatment apparatus using a dialyzer for blood treatment, the present invention is not limited thereto, and its application in other medical technology fields other than for treating patients with impaired renal function is also within the scope of the present invention.

[0164] Reference Signs List

[0165] 100 Blood processing equipment

[0166] 101 Blood Pump

[0167] 102 Dialysis fluid outlet line

[0168] 102a connector

[0169] 104 Dialysis fluid inlet line

[0170] 104a connector

[0171] 105 Replacement fluid line

[0172] 107 Predilution Valve

[0173] 107a Pre-dilution valve related pipeline

[0174] 109 Post-dilution valve

[0175] 109a Post-dilution valve related pipelines

[0176] 111 Displacement Fluid Pump

[0177] 131 Ultrafiltration Pump

[0178] 150 Control or regulating device

[0179] 151 Storage Devices

[0180] 153 Discharge device

[0181] 155 Water Source

[0182] 157 Heat Exchanger

[0183] 159 First flow pump

[0184] 161 Balancing Device

[0185] 162 Heating device

[0186] 163 Mixing device

[0187] 163a Conductivity Sensor

[0188] 163b Conductivity Sensor

[0189] 165a First temperature sensor

[0190] 165b Second temperature sensor

[0191] 165c ambient temperature sensor

[0192] 166 Concentrate supply device

[0193] 167 Leak Sensor

[0194] 168 Concentrate supply device

[0195] 169 Second flow pump

[0196] 171 Pump, sodium pump

[0197] 173 Pumps, bicarbonate pumps

[0198] 300 Extracorporeal Blood Circuit

[0199] 301 First pipeline (arterial pipeline segment)

[0200] 302 (First) Pipe Clamp

[0201] 303 Blood filter or dialyzer

[0202] 303a Dialysis fluid chamber

[0203] 303b Blood Chamber

[0204] 303c semipermeable membrane

[0205] 304a Dialysate Port

[0206] 304b Dialysate Port

[0207] 305 Second line (venous line segment)

[0208] 306 (Second) Pipe Clamp

[0209] 315 detector

[0210] 317 Single Needle Chamber

[0211] 318 Degassing device

[0212] 319 detector

[0213] 325 Heparin addition site

[0214] 329 Venous Blood Chamber (Optional)

[0215] 350 Short-circuit pipeline; short circuit

[0216] 360 shell wall

[0217] F1 filter

[0218] F2 filter

[0219] A container; A concentrate; sodium

[0220] B container; B concentrate; bicarbonate

[0221] K Compressed air source; compressor

[0222] L1 Length of the first pipeline segment

[0223] L2 Length of the second pipeline segment

[0224] P pressure measurement point

[0225] PS1 arterial pressure sensor (optional)

[0226] PS2 arterial pressure sensor (optional)

[0227] PS3 pressure sensor (optional)

[0228] PS4 Pressure sensor for measuring filtrate pressure (optional)

[0229] PS5 Pressure sensor for measuring the pressure in the dialysis fluid inlet line

[0230] T1 first temperature value

[0231] T2 Second temperature value

[0232] T D Dialyzer temperature

[0233] Tk Temperature coefficient

[0234] T rech Calculate temperature value

[0235] T D_soll Temperature setting at blood processing equipment

[0236] T 1_soll Temperature setting value at the first temperature sensor

[0237] T Umg Ambient temperature value

[0238] V valve

[0239] V24 valve

[0240] V25 valve

[0241] VB Bypass Valve

[0242] YY type connector

Claims

1. A control or regulating device (150) configured to control or regulate the operation of a blood treatment apparatus (100) for treating a patient during a blood treatment session, wherein the blood treatment apparatus (100) is connected to an extracorporeal blood circuit (300) and a blood treatment device, such as a dialyzer (303) or a blood filter, and further comprising: a dialysis fluid inlet line (104) and a dialysis fluid outlet line (102) configured to supply dialysis fluid to or drain dialysis fluid from the blood treatment device (303), respectively, during the blood treatment session; - a heating device (162) for heating the dialysis fluid before or during the blood treatment period; - one or more temperature sensors (165a, 165b), wherein at least a first temperature sensor (165a) is arranged downstream of the blood treatment device and / or downstream of the dialysis fluid inlet line (104) for determining a first temperature value (T1) of a first liquid previously flowing in the dialysis fluid inlet line (104); Therein, the control or regulating device (150) is configured to increase or set the temperature of the dialysis fluid using the heating device (162) based on the first temperature value (T1) determined by the first temperature sensor (165a).

2. The control or regulating device (150) according to claim 1, wherein: The control or regulating device (150) is configured to increase or set the temperature using the heating device (162) additionally based on a second temperature value (T2), which is determined or has been determined by a second temperature sensor (165b) of a plurality of temperature sensors (165a, 165b) for a first liquid upstream of the blood treatment device and / or upstream of the dialysate outlet line (102).

3. A control or regulating device (150) according to any one of the preceding claims, wherein: The first temperature value (T1) and / or the second temperature value (T2) is determined or has been determined before the start of a blood treatment session.

4. A control or regulating device (150) according to any one of the preceding claims, wherein: The first temperature value (T1) and / or the second temperature value (T2) is determined or has been determined during a blood treatment session.

5. A control or regulating device (150) according to any one of the preceding claims, wherein: The first temperature value (T1) or the second temperature value (T2) is determined or has been determined when the dialysis fluid inlet line (104) and the dialysis fluid outlet line (102) are in fluid communication with each other while excluding or bypassing the blood treatment device.

6. A control or regulating device (150) according to any one of the preceding claims, wherein: The first temperature value (T1) and / or the second temperature value (T2) is determined or has been determined when the dialysis fluid inlet line (104) and the dialysis fluid outlet line (102) are not arranged in such a way as to exclude or bypass the blood treatment device.

7. The control or regulating device (150) according to claim 6, wherein: When determining the first temperature value (T1) and / or the second temperature value (T2) or for determining the first temperature value (T1) and / or the second temperature value (T2), no two different liquids flow through the blood treatment device or are present in it.

8. A control or regulating device (150) according to any one of the preceding claims, wherein: Determine the first temperature value (T1) of the first liquid and the temperature setting value (T 1_soll ) between .

9. A control or regulating device (150) according to any one of the preceding claims, wherein: The control device or regulating device (150) is configured to: - calculating a calculated temperature value (T) based on the first temperature value (T1) and the second temperature value (T2) of the first liquid rech ); - Determine the calculated temperature value (T rech ) and the set value (T D_soll ) as well as - Based on the calculated temperature value (T rech ) and the set value (T D_soll ) causes the heating device (162) to increase or set the dialysis fluid temperature.

10. The control or regulating device (150) according to claim 9, wherein: The calculated temperature value (T rech ) is based on the first temperature value (T1) and / or the second temperature value (T2) and the temperature coefficient (T k ) is determined or has been determined, wherein the temperature coefficient (T k ) for the dialysis fluid inlet line (104) or in particular a first line segment extending outside the blood treatment device (100), in particular a length (L1) of the first line segment and / or for the dialysis fluid outlet line (102) or in particular a second line segment extending outside the blood treatment device (100), in particular a length (L2) of the second line segment is determined or has been determined.

11. The control or regulating device (150) according to claim 10, wherein: The control or regulation means (150) is configured to determine the temperature coefficient (T k ).

12. The control or regulating device (150) according to claim 10 or 11, wherein: The control or regulation device (150) is configured to determine the temperature coefficient (T) associated with one, two or more flow rates (Q1, Q2, Q3) of a first liquid flowing through or into the blood treatment device or through or into a short circuit between the dialysis fluid inlet line (104) and the dialysis fluid outlet line (102) that excludes or bypasses the blood treatment device. k ).

13. The control or regulating device (150) according to any one of claims 8 to 12, wherein: The control or regulation device (150) is configured to increase or decrease the temperature of the dialysis fluid achieved during or before the blood treatment period using the heating device (162) by a first temperature value (T1) and a first temperature setting value (T 1_soll ) or at least the difference, or the calculated temperature value (T rech ) and the temperature setting value of the blood processing device (T D_soll ) or at least the difference.

14. A control or regulating device (150) according to any one of the preceding claims, wherein: The first temperature value (T1) is determined only downstream of the blood treatment device.

15. A control or regulating device (150) according to any one of the preceding claims, wherein: The control or regulating device (150) is configured to further take into account an ambient temperature value (T) determined by an ambient temperature sensor (165c), for example an ambient temperature sensor of the blood treatment apparatus (100), when increasing or setting the temperature of the dialysis liquid reached by the heating device (162) during or before the blood treatment period. Umg ).

16. A blood treatment apparatus (100) configured for use in conjunction with an extracorporeal blood circuit (300) and a blood treatment device, such as a dialyzer (303) or a blood filter, for treating a patient's blood during a blood treatment session, the blood treatment apparatus comprising: at least one receptacle for releasably receiving at least a portion of the extracorporeal blood circuit (300) on the blood treatment apparatus (100); - at least one receiving portion for releasably receiving at least a portion of the blood treatment device on the blood treatment apparatus (100); a dialysis fluid inlet line (104) and a dialysis fluid outlet line (102) configured to supply dialysis fluid to and drain dialysis fluid from the blood treatment apparatus (100) or its receptacle, respectively, during a blood treatment session; - one or more temperature sensors (165a, 165b), wherein at least a first temperature sensor (165a) is arranged downstream of the blood treatment device and / or downstream of the dialysis fluid inlet line (104) for determining a first temperature value (T1) of a first fluid flowing through or remaining in the dialysis fluid inlet line (104); - a heating device (162) for heating the dialysis fluid during or before a blood treatment session; - A control or regulating device (150) according to any one of the preceding claims, for controlling or regulating the operation of the blood treatment apparatus (100).

17. The blood treatment apparatus (100) according to claim 16, wherein: The blood treatment apparatus (100) further comprises a second temperature sensor (165b) among the plurality of temperature sensors (165a, 165b) for determining a second temperature value (T2) of the first liquid upstream of the blood treatment device or upstream of the dialysate outlet line (102).

18. The blood treatment apparatus (100) according to claim 16 or 17, wherein: The blood treatment device (100) further comprises an ambient temperature sensor (165c) or is connected to the ambient temperature sensor (165c), wherein the ambient temperature sensor is used to determine an ambient temperature value (T Umg ).

19. The blood treatment apparatus (100) according to any one of claims 16 to 18, wherein: The blood treatment apparatus (100) is implemented as a dialysis apparatus, a hemodialysis apparatus, a hemofiltration apparatus or a hemodiafiltration apparatus, in particular as an apparatus for acute renal replacement therapy, chronic renal replacement therapy or continuous renal replacement therapy (CRRT).

20. A digital storage medium, in particular a floppy disk, a memory card, a CD or DVD, an EPROM, a FRAM or an SSD, having electronically readable control signals, the digital storage medium being configured to interact with a programmable computer system in order to reprogram a conventional control or regulating device into a control or regulating device (150) according to any one of claims 1 to 15 and / or to reprogram a conventional blood treatment apparatus into a blood treatment apparatus (100) according to any one of claims 16 to 19.

21. A computer program product, which is a signal wave or has a program code stored on a machine-readable carrier, and is used to interact with a programmable computer system to reprogram a conventional control device or regulating device into a control device or regulating device (150) according to any one of claims 1 to 15, and / or reprogram a conventional blood treatment device into a blood treatment device (100) according to any one of claims 16 to 19.

22. A computer program having a program code, wherein the program code is configured to reprogram a conventional control device or regulating device into a control device or regulating device (150) according to any one of claims 1 to 15, or to reprogram a conventional blood treatment device into a blood treatment device (100) according to any one of claims 16 to 19, when the computer program is run on a computer.

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