Blood treatment device with compensation for changes in ambient temperature

Abstract

The invention relates to an open-loop or closed-loop control device (150) configured for the open-loop or closed loop control of the operation of a blood treatment device (100) for treating a patient during a blood treatment session in which the blood treatment device (100) is connected to an extracorporeal blood circuit (300) and a blood treatment unit, e.g. a dialyser (303) or blood filter. The blood treatment device (100) also comprises a dialysis fluid supply line (104) and a dialysate discharge line (102), a heating device (162) for heating the dialysis fluid and one or more temperature sensors (165a, 165b), of which at least a first temperature sensor (165a) is arranged downstream of the blood treatment unit and / or downstream of the dialysis fluid supply line (104), for determining a first temperature value (T1) of a first fluid previously guided along the dialysis fluid supply line (104). The open-loop or closed-loop control device (150) is configured to increase or adjust the temperature of the dialysis fluid by means of the heating device (162) based on the first temperature value (T1) determined by the first temperature sensor (165a).

Description

[0001] Description

[0002] Blood treatment device with compensation for changes in ambient temperature

[0003] The present invention relates to a control or regulating device according to claim 1, a blood treatment device 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 according to the respective preambles or generic terms of these claims.

[0004] Blood treatment devices are known in practice which administer a treatment fluid to the patient by means of a pump, often, as in the example of a dialysis device, via the extracorporeal blood circuit. In blood treatment devices such as dialysis devices, treatment fluid is fed additionally or alternatively, for example, to a blood filter through which blood flows. Since the temperature of the pumped treatment fluid can influence the temperature of the blood to be reinfused into the patient in both of the aforementioned cases, a heating device can be provided for warming or tempering the treatment fluid.

[0005] An object of the present invention is to specify a further control or regulating device and a further blood treatment device. In addition, a digital storage medium, a computer program product and a computer program are to be specified. The object according to the invention can be achieved by means of a control or regulating device having the features of claim 1 and / or by means of a blood treatment device having the features of claim 16. Furthermore, it can be achieved by means of a digital storage medium having the features of claim 20, by means of a computer program product having the features of claim 21 and / or by means of a computer program having the features of claim 22.

[0006] The present invention relates to a control or regulating device configured to control or regulate the operation of a blood treatment device for treating a patient during a blood treatment session, in which the blood treatment device is connected to an extracorporeal blood circuit and a blood treatment device, e.g. a dialyzer or a blood filter.

[0007] The blood treatment device further comprises a dialysis fluid supply line, which is arranged to supply dialysis fluid to the blood treatment device during the blood treatment session, and a dialysate drain line, which is arranged to remove dialysate, i.e. used dialysis fluid, from the blood treatment device during the blood treatment session.

[0008] A heating device for warming the dialysis fluid before or during the blood treatment session is also included in the blood treatment device.

[0009] The blood treatment device further comprises one or more temperature sensors. These can be thermometers or devices by means of which a temperature can be estimated.

[0010] At least a first of these temperature sensors, which is arranged downstream of the blood treatment device and / or downstream of the dialysis fluid supply line, serves to determine a first temperature value of a first fluid previously guided along the dialysis fluid supply line in the direction of the blood treatment device.

[0011] Here, the control or regulating device is configured to increase or adjust the temperature of the dialysis fluid by means of the heating device based on the first temperature value which was determined by the first temperature sensor.

[0012] According to the invention, a blood treatment device is proposed which is prepared for use with an extracorporeal blood circuit and a blood treatment device, e.g. a dialyzer or a blood filter, for treating the blood of a patient during a blood treatment session.

[0013] The blood treatment device according to the invention comprises at least one receptacle for detachably receiving at least one section of the extracorporeal blood circuit on the blood treatment device.

[0014] Furthermore, the blood treatment device according to the invention comprises at least one receptacle for detachably receiving at least a portion of the blood treatment device on the blood treatment device. The blood treatment device according to the invention further comprises a dialysis fluid supply line, which is arranged to supply dialysis fluid to the blood treatment device during the blood treatment session, and a dialysate drain line, which is arranged to remove dialysate, i.e., used dialysis fluid, from the blood treatment device during the blood treatment session.

[0015] It further comprises one or more temperature sensors, which may be thermometers or devices for estimating a temperature. At least one first temperature sensor of these temperature sensors is arranged downstream of the blood treatment device and / or downstream of a dialysis fluid supply line. It serves to determine a first temperature value of a first fluid flowing through the dialysis fluid supply line or resting therein.

[0016] A heating device serves to heat the dialysis fluid before or during the blood treatment session and is also included in the blood treatment device according to the invention.

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

[0018] A digital, in particular non-volatile, storage medium according to the invention, in particular in the form of a machine-readable carrier, in particular in the form of a floppy disk, memory card, CD, DVD, EPROM, FRAM (Ferroelectric RAM) or SSD (Solid State Drive), in particular with electronically or optically readable control signals, can interact with a programmable computer system in such a way that a conventional control or regulating device is reprogrammed into a control or regulating device according to the invention. Alternatively or additionally, a conventional blood treatment device is reprogrammed into a blood treatment device according to the invention.

[0019] A computer program product according to the invention comprises a volatile, transient program code or a signal wave stored on a machine-readable medium, by means of which a conventional control or regulating device is reprogrammed into a control or regulating device according to the invention when the computer program product is run on a computer. Alternatively or additionally, a conventional blood treatment device is reprogrammed into a blood treatment device according to the invention.

[0020] According to the invention, a computer program product can be, for example, a computer program stored on a carrier, an embedded system as a comprehensive system with a computer program (e.g. electronic device with a computer program), a network of computer-implemented computer programs (e.g.

[0021] Client / server system, cloud computing system, etc.) or a computer on which a computer program is loaded, running, stored, executed or developed. The term “machine-readable medium” as used herein refers, in certain embodiments of the present invention, to a medium containing data or information that can be interpreted by software and / or hardware. The medium can be a data carrier such as a floppy disk, CD, DVD, USB stick, flash card, SD card and the like, as well as any other memory or storage medium mentioned herein.

[0022] A computer program according to the invention comprises a program code by means of which a conventional control or regulating device is reprogrammed into a control or regulating device according to the invention when the computer program is run on a computer. Alternatively or additionally, a conventional blood treatment device is reprogrammed into a blood treatment device according to the invention.

[0023] Embodiments of the invention may have some, some or all of the following features in any combination, unless this is recognizably technically impossible for a person skilled in the art.

[0024] In all statements made above and in all 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 embodiments of the invention.

[0025] 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 the reference to "a" or "an" as "at least one" or "at least one". 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 for the person skilled in the art. Both are encompassed by 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," the skilled person will understand this to refer to the arrangement in the figures attached here and / or in the state of use. "Bottom" is closer to the center of the earth or the lower edge of the figure than "top."

[0027] When reference is made herein to "determine", in particular to data and / or temperature values, this can be or include investigating existence or non-existence, measuring, determining, capturing, recording, collecting, evaluating, processing, comparing, estimating, assessing or estimating, deducing, calculating, obtaining, achieving and / or recognizing.

[0028] Advantageous further developments of the present invention are the subject of subclaims and embodiments.

[0029] When an embodiment is mentioned herein, it represents an exemplary embodiment of the invention, which is not to be understood as limiting. If it is disclosed herein that the subject matter of the invention has one or more features in a specific embodiment, it is also disclosed herein that the subject matter of the invention expressly does not have precisely this or these features in other, likewise inventive embodiments, e.g. in the sense of a disclaimer. For each embodiment mentioned herein, it therefore applies that the opposite embodiment, for example formulated as a negation, is also disclosed.

[0030] When reference is made to programmed or configured, these terms may be interchangeable in some embodiments.

[0031] Whenever reference is made here to a signal or communication connection between two components, this may be understood as a connection that is already in use. It may also be understood as preparation for such a signal connection (wired, wireless, or implemented in another way), for example, by coupling the two components, such as by pairing, etc.

[0032] Pairing is a process that occurs in connection with computer networks in order to establish an initial link between computer units for the purpose of communication. The best known example of this is establishing a Bluetooth connection, by means of which various devices (e.g. smartphone, headphones) are connected to one another. Pairing is occasionally also referred to as bonding. The control or regulating device can initiate the execution of all or substantially all of the method steps. The method according to the invention can be carried out substantially or completely by the control device. It can be partially carried out by the control device; in particular, those steps which do not require or involve human intervention and / or provision can be carried out by the control device. The control device can serve as a pure control device or also as a regulating device.

[0033] In some embodiments, the control or regulating device is present in or on the blood treatment device, for example together with other components or devices of the blood treatment device in a common housing of the blood treatment device.

[0034] In some embodiments, the control or regulating device according to the invention is configured to additionally increase or adjust the temperature by means of the heating device based on a second temperature value. The second temperature value can be determined or have been determined by means of a second temperature sensor of the plurality of temperature sensors on the first liquid upstream of the blood treatment device and / or upstream of the dialysate drain line.

[0035] In some embodiments, the first and / or second temperature values ​​are or were determined before the start of the blood treatment session. The first and / or second temperature values ​​can be stored in the control or regulating device or in a storage device suitable or provided for this purpose.

[0036] In some embodiments, the first and / or second temperature values ​​are or were determined during the blood treatment session.

[0037] In some embodiments, the first or second temperature value is or was determined while the dialysis fluid inlet line and the dialysate outlet line are or were fluidly connected to one another, excluding or bypassing the blood treatment device, for example by means of a short-circuit line.

[0038] In some embodiments, the first and / or the second temperature value are or were determined while the dialysis fluid inlet line and the dialysate outlet line are or were not arranged excluding or bypassing the blood treatment device, but are each connected to the blood treatment device, for example in fluid communication.

[0039] In some embodiments of the control or regulating device according to the invention, no two different fluids flow through or are at rest in the blood treatment device during or for determining the first and / or second temperature value. In particular, no blood flows or is at rest therein as a second fluid.

[0040] In some forms of tax or

[0041] Control device determines a deviation of the first temperature value of the first liquid from a setpoint value for this liquid at this point.

[0042] In some embodiments of the control or regulating device, it is configured to calculate a calculated temperature value which is based on both the first temperature value and the second temperature value of the first liquid, to determine a deviation of the calculated temperature value at the blood treatment device from a setpoint value for the temperature at this point and to cause the temperature of the dialysis liquid to be increased or adjusted by means of the heating device based on the deviation of the calculated temperature value at the blood treatment device from a setpoint value for the blood treatment device.

[0043] In some embodiments, a target temperature for the temperature value at the dialyzer, which is required to determine a deviation of the temperature value at the dialyzer from this, and / or a target temperature for the temperature value at the first temperature sensor, which is required to determine a deviation of the measured first temperature value from the target temperature at the first temperature sensor, are entered by the user, for example via an input interface of the blood treatment device. Alternatively, these target values ​​are stored in a storage device provided for this purpose and can be retrieved from there by the control or regulating device.

[0044] In some embodiments, the calculated temperature value at the blood treatment device is or was determined or calculated based on the first and / or second temperature value and a temperature coefficient, determined for the dialysis fluid inlet line or a first line section, in particular running outside the blood treatment device, in particular its length, and / or for the dialysate outlet line, or a second line section, in particular running outside the blood treatment device, in particular its length.

[0045] Calculating the calculated temperature value at the blood treatment device or the dialyzer yields an estimate of the actual temperature of the first fluid as it flows through the blood treatment device. This can be used to determine a deviation between the estimated temperature at the blood treatment device and its target value at this point. The deviation is used to initiate, according to the invention, the increase or adjustment of the temperature of the dialysis fluid by means of the heating device based on the deviation of the calculated temperature value from its target value.

[0046] For a calculated temperature value T rec h in the dialyzer in one embodiment

[0047] Trech = T2 — LI * T k or

[0048] Trech — TL + L2 * T k and for the temperature at the first temperature sensor

[0049] TI = T2 - ((LI + L2) * T k ) .

[0050] In some embodiments, the control or regulating device is configured to determine the temperature coefficient Tk.

[0051] If a linear temperature drop is assumed for the respective line length of the line sections LI, L2, a temperature coefficient Tk in the unit [° C / m] can be defined, for example, as follows:

[0052] (T2 - TI) k LI + L2 ' where :

[0053] TI measured first temperature value from the first temperature sensor downstream of the dialyzer

[0054] T2 measured second temperature value from the second temperature sensor upstream of the dialyzer

[0055] LI Length of the line preferably outside the blood treatment device upstream of the dialyzer

[0056] L2 Length of the line preferably outside the blood treatment device downstream of the dialyzer

[0057] In some embodiments, the control or regulating device is configured to determine the temperature coefficient based on one, two or more, in particular predetermined, flow velocities of the first liquid into or through the blood treatment device. Alternatively, the temperature coefficient is or was determined for one, two or more, in particular predetermined, flow velocities of the first liquid by means of a short circuit, for example, by means of a short-circuit line, between the dialysis fluid inlet line and the dialysate outlet line, while excluding or bypassing the blood treatment device.

[0058] If a linear relationship between temperature drop and flow is assumed, then for a reference flow of 500 ml / min:

[0059] 500 ml / min,

[0060] The influence of an ambient temperature value Tumg In these calculations, in certain embodiments, it is assumed to be homogeneous.

[0061] In some embodiments, the control or regulating device according to the invention is configured to increase or decrease the temperature of the dialysis fluid, to which the dialysis fluid is heated by means of the heating device during or before the blood treatment session, by the difference between the first temperature value or the calculated temperature value and the respective setpoint value for the temperature at these points.

[0062] In some embodiments of the control or regulating device, only the first temperature value downstream of the blood treatment device is determined.

[0063] In some embodiments, the control or regulating device is configured to further take into account a determined ambient temperature value when increasing or adjusting the temperature of the dialysis fluid to which the dialysis fluid is heated by the heating device during or before the blood treatment session. The ambient temperature value can be or have been determined, for example, by means of an ambient temperature sensor, e.g., a temperature sensor of the blood treatment device.

[0064] In some embodiments, the blood treatment device according to the invention further comprises a second temperature sensor among the plurality of temperature sensors, which serves to determine a second temperature value of the first liquid upstream of the blood treatment device or upstream of the dialysate drain line.

[0065] In some embodiments, the blood treatment device further comprises or is connected to an ambient temperature sensor. The ambient temperature sensor is suitable and / or provided for determining an ambient temperature value of the blood treatment device.

[0066] In certain embodiments, the ambient sensor is in signal communication with the control or regulating device and can transmit the measured ambient temperature value to it. Alternatively, this temperature value can be retrieved from the ambient temperature sensor via the control or regulating device.

[0067] In some embodiments, the blood treatment device is designed as a dialysis device, hemodialysis device, hemofiltration device or hemodiafiltration device, in particular as a device for acute, chronic renal replacement therapy or for continuous renal replacement therapy (CKRT = continuous kidney replacement therapy).

[0068] In some embodiments, the present invention is not limited to the use of a blood treatment device that uses a dialyzer for blood treatment. It also encompasses its use in other areas of medical technology that do not serve the treatment of patients with kidney damage.

[0069] In some embodiments, internal device influences, particularly temperature influences, are included in the calculation as described herein; in others, these are neglected. Such consideration can be made, for example, when determining the temperature coefficient Tk. Thus, a series of temperature coefficients Tk can be determined under different, predetermined ambient conditions and, above all, temperatures and optionally stored, for example, in the memory device.

[0070] In some embodiments, values, target values, coefficients, and the like disclosed herein can optionally be determined or calculated by the control or regulating device within the scope of the present disclosure, for example by means of a corresponding computing device which is comprised by the control or regulating device or is connected thereto. They can alternatively be taken from a storage device. These values, target values, coefficients, and the like can be stored there after they have first been determined by the control or regulating device or the computing device in a previous step or at an earlier point in time.

[0071] If method steps are mentioned herein, it is provided in some embodiments that these take place before or after a treatment of the patient, for example while the patient is not connected to the device, e.g. by means of extracorporeal blood circulation or the like, or that a treatment has not yet begun or has already ended.

[0072] In some embodiments, no patient body temperature and / or a temperature correlated therewith is measured or determined, and / or the temperature sensors are not arranged for this purpose. In some embodiments, the body temperature or values ​​thereof are not included in the calculation or determination performed or initiated by the control or regulating device or another component, or in the control.

[0073] In some embodiments, the control or regulating device does not take into account the body temperature of the patient and / or a temperature correlating therewith when adjusting or increasing the temperature of the dialysis fluid by means of the heating device.

[0074] In some embodiments, no quantity that is a characteristic of the heat transfer through the dialyzer is taken into account in the calculation or determination performed or initiated by the control or regulating device or another component, or in the control. Some or all embodiments of the invention may have one, several, or all of the advantages mentioned above and / or below.

[0075] One advantage of the present invention may be that the heating power of the heating device is subject to temperature-based control, thus ensuring that the temperature at the predetermined location does not exceed a maximum temperature and / or does not fall below a target temperature. Corresponding adjustments of the pump's delivery rates for delivering the treatment fluid with regard to the above temperature values ​​can be omitted, and the patient can be protected from the consequences of using a treatment fluid of an unsuitable temperature.

[0076] According to the invention, the temperature at the temperature sensors or a heat loss of the treatment liquid between the first and the second temperature sensor can be determined using simple means and then known, thus temperature differences can be advantageously detected and the heating device can be controlled accordingly.

[0077] A further advantage of the present invention may be that existing systems can be easily retrofitted by means of a software update, since already existing sensors of the blood treatment device as well as its control or regulating device can be used.

[0078] The present invention is described below purely by way of example with reference to the accompanying figures. Like reference numerals designate like or similar components. The following applies: Fig. 1 shows a simplified schematic of a fluid line structure of a blood treatment device according to the invention in a first embodiment;

[0079] Fig. 2 shows a section of the fluid line structure of Fig. 1, in which, instead of the blood treatment device, a short-circuit line connects the dialysis fluid inlet line and the dialysate outlet line; and

[0080] Fig. 3 shows a simplified schematic of a control or regulating device according to the invention with temperature data streams.

[0081] Fig. 1 shows a fluid line structure of a blood treatment device 100 according to the invention in a first embodiment. The blood treatment device is represented in Fig. 1 only by individual, partially highly simplified schematic components.

[0082] The blood treatment device 100, which is shown in an at least partially equipped state of use, is connected to an extracorporeal blood circuit 300, which can be connected to the vascular system of the patient (not shown) for treatment by means of double-needle access, or using, for example, an additional Y-connector (reference symbol Y) as shown in Fig. 1, by means of single-needle access and optionally does not belong to the blood treatment device 100, in other

[0083] However, in some embodiments, this is possible. The blood circuit 300 can optionally be present in sections in or on a blood cassette. Pumps, actuators, and / or valves in the region of the blood circuit 300 are connected by signal to the blood treatment device 100 according to the invention or to a control or regulating device 150 comprised therein, for example, where necessary for control or regulation.

[0084] The blood circuit 300 has (or is connected to) an arterial patient tube clamp 302 and an arterial connection needle (not shown in Fig. 1) of an arterial section or an arterial patient line, blood sampling line or first line 301.

[0085] The blood circuit 300 further comprises (or is connected to) a venous patient tube clamp 306 and a venous connection needle (not shown in Fig. 1) of a venous section, a venous patient line, blood return line or second line 305.

[0086] A blood pump 101 is provided in or on the first line 301, an optional substituate pump 111 is connected, for example, to a dialysis fluid supply line 104 for conveying fresh dialysis fluid, which is filtered (substituate) in a filter stage (filter F2).

[0087] An optional substituate line 105 can be fluidically connected, for example, to a dialysis fluid supply line 104. By means of the substituate pump 111, substituate can be supplied by predilution, via an optional predilution valve 107, or by postdilution, via an optional

[0088] Post-dilution valve 109, via optional, associated lines 107a or 109a into line sections, for example into the arterial line section 301 or into the venous line section 305 (here between a blood chamber 303b of a blood filter 303 and a venous air separation chamber or a venous bubble trap 329) of the blood circuit 300.

[0089] The blood filter 303 has the blood chamber 303b connected to the arterial line section 301 and to the venous line section 305. A dialysis fluid chamber 303a of the blood filter 303 is connected to the dialysis fluid inlet line 104 leading to the dialysis fluid chamber 303a and to a dialysate outlet line 102 leading away from the dialysis fluid chamber 303a and carrying dialysate, i.e., used dialysis fluid. Suitable connectors 104a, 102a on the dialysis fluid inlet line 104 and on the dialysate outlet line 102, respectively, on the one hand, and dialysate ports 304a, 304b of the blood filter 303, on the other hand, are used for this purpose; these connectors can be connected to one another, in particular detachably.

[0090] Dialysis fluid chamber 303a and blood chamber 303b are separated from each other by a mostly semi-permeable membrane 303c. This represents the dividing wall between the blood side with the extracorporeal blood circuit 300 and the machine side with the dialysis fluid or dialysate circuit, which is shown in Fig. 1 to the left of the membrane 303c.

[0091] The arrangement of Fig. 1 includes an optional detector 315 for detecting air and / or blood. The arrangement of Fig. 1 optionally further includes one or two pressure sensors PS1 (upstream of the blood pump 101) and PS2 (downstream of the blood pump 101; it measures the pressure upstream of the blood filter 303 ("pre-hemo filter")) at the locations shown in Fig. 1. Additional pressure sensors may be provided, e.g., the pressure sensor PS3 downstream of the venous bubble trap 329.

[0092] An optional single-needle chamber 317 is used in Fig. 1 as a buffer and / or compensation container in a single-needle procedure in which the patient is connected to the extracorporeal blood circuit 300 by means of only one of the two blood lines 301, 305.

[0093] An addition site 325 for heparin or another, particularly local, anticoagulant may optionally be provided.

[0094] On the left in Fig. 1, an optional mixing device 163 is shown, which prepares a predetermined mixture for the respective solution for use by the blood treatment device 100 from containers A (for A concentrate via concentrate supply 166) and B (for B concentrate via concentrate supply 168). The solution contains water from the water source 155 (online, e.g., as reverse osmosis water or from bags), which is heated, e.g., in the heating device 162.

[0095] An optional pump 171, which may be referred to as a concentrate pump or sodium pump, is fluidly connected to and / or pumps from the mixing device 163 and a source of sodium, such as container A.

[0096] An optional pump 173, which is assigned to container B, for example, for bicarbonate, can be seen. Furthermore, an outlet 153 for the effluent can be seen in Fig. 1. An optional heat exchanger 157 and an optional first flow pump 159, which is suitable for degassing, complement the arrangement shown.

[0097] The optional pressure sensor PS4 downstream of the blood filter 303 on the water side, but preferably upstream of an optional ultrafiltration pump 131 in the dialysate drain line 102, can be provided for measuring the filtrate pressure or membrane pressure of the blood filter 303.

[0098] The ultrafiltration pump 131 represents a means for precisely removing a volume of liquid specified by the user and / or by the control or regulating device 150 from the balanced circuit.

[0099] Blood leaving the blood filter 303 flows through an optional venous bubble trap 329, which may have a venting device 318 and may be in fluid communication with the pressure sensor PS3.

[0100] The exemplary arrangement shown in Fig. 1 comprises the control or regulating device 150 according to the invention. The latter can be in wired or wireless signal connection with any of the components mentioned herein—in any case or in particular with the blood pump 101—for controlling or regulating the blood treatment device 100.

[0101] By means of the device for online mixing of the dialysis fluid, a variation of its sodium content is possible within certain limits, controlled by the control or regulating device 150. For this purpose, the measured values ​​determined by conductivity sensors 163a, 163b can be included, in particular. Should an adjustment of the sodium content of the dialysis fluid (sodium concentration) or of the substituate prove necessary or desired, this can be achieved by adjusting the delivery rate of the sodium pump 171.

[0102] In addition, the blood treatment device 100 comprises means for conveying fresh dialysis fluid and dialysate. An optional first valve V24 can be provided between the first flow pump 159 and the blood filter 303, which opens or closes the inlet to the blood filter 303 on the inlet side. A second, optional flow pump 169 is provided, for example, downstream of the blood filter 303, which pumps dialysate to the outlet 153. A second valve V25 can be provided between the blood filter 303 and the second flow pump 169, which opens or closes the outlet on the outlet side.

[0103] Furthermore, the blood treatment device 100 optionally comprises a device 161 for balancing the flow flowing into and out of the dialyzer 303 on the machine side. The balancing device 161 is preferably arranged in a line region between the first flow pump 159 and the second flow pump 169.

[0104] Sensors such as the optional conductivity sensors 163a, 163b are used to determine the conductivity, which in some embodiments is temperature compensated, as well as the liquid flow upstream and downstream of the dialyzer 303.

[0105] Temperature sensors, among them the first temperature sensor

[0106] 165a and / or the second temperature sensor 165b may be provided individually or in multiples.Temperature values ​​supplied by them can be used during the treatment of the patient to determine a temperature-compensated conductivity, during the blood 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), or according to the invention to determine at least a first temperature value Ti of the fluid flowing downstream of the dialyzer and out of it (which could be referred to as dialysate during the blood treatment, which is also done here in accordance with the invention) and / or at least a second temperature value T2 of the fluid flowing upstream of the dialyzer and into it (which could be referred to as dialysis fluid during the blood treatment, which is also done here in accordance with the invention).

[0107] A leakage sensor 167 is provided as an option. Alternatively, it can also be installed elsewhere.

[0108] Further flow pumps, in addition to or as an alternative to, for example, that with the reference number 169, may also be provided.

[0109] A number of optional valves are designated V in Fig. 1. Bypass valves are designated VB.

[0110] A pressure sensor PS5 for measuring the pressure in the dialysis fluid supply line 104 may be provided.

[0111] Based on the measured values ​​of the aforementioned optional sensors, in some embodiments, the control or regulating device 150 determines the electrolyte and / or fluid balance. Filters F1 and F2 can be connected in series.

[0112] The filter Fl serves here as an example to produce sufficiently pure dialysis fluid by means of the mixing device 163 even using non-pure water, which then flows through the blood filter 303, e.g. in the countercurrent principle.

[0113] The filter F2 serves here as an example to generate sterile or sufficiently filtered substituate from the sufficiently pure dialysis fluid which leaves the first filter Fl by filtering out, for example, pyrogenic substances, which can be safely added to the patient's extracorporeal blood and thus ultimately to the patient's body.

[0114] An optional ambient temperature sensor 165c, which may be part of the blood treatment device 100, may be connected in signal communication to the control or regulating device 150 thereof in order to measure an ambient temperature value Tu mg(see Fig. 3). The control or regulating device 150 can be configured to further increase or adjust the temperature by further increasing this determined ambient temperature value Tu mg to be taken into account .

[0115] The ambient temperature sensor 165c can also be provided separately from the blood treatment device 100, but still be in signal communication with its control or regulating device 150. The blood treatment device 100 is optionally shown in Fig. 1 as a device for hemodiafiltration. However, hemodialysis devices also fall within the scope of the present invention, although not specifically illustrated in the figure.

[0116] The arrowheads shown in Fig. 1 generally indicate the direction of flow.

[0117] Fig. 2 shows a section of the fluid line structure of Fig. 1, in which instead of the blood treatment device 303 a short-circuit line 350 dialysis fluid supply line 104 and

[0118] Dialysate drain line 102 connects, which is equivalent to bypassing the blood filter 303. Such a short circuit can be used, for example, prior to an upcoming blood treatment in order to first test all relevant components of the blood treatment device 100 for their functionality.

[0119] Reference is made to the description of Fig . 1 .

[0120] The dialyzer or blood filter 303, together with the extracorporeal blood circuit 300 and its pumps, actuators and / or valves, is in a not yet equipped state in the example of Fig. 2 and is therefore shown separately from the hydraulics of the blood treatment device 100.

[0121] A housing wall 360 of the blood treatment device 100 is indicated by a double line. It is assumed according to the invention that a temperature of the dialysis fluid or of the dialysate inside the blood treatment device 100 (i.e. to the left of the housing wall 360) does not change, whereas the dialysis fluid or the dialysate is exposed to an ambient temperature along the hoses or line sections which run over definable lengths L1, L2 outside the blood treatment device 100 (to the right of the housing wall 360 in Fig. 2). The latter can bring about a change in the temperature of the dialysis fluid or of the dialysate. A change in the temperature of the dialysis fluid (i.e. the temperature towards or away from the dialyzer)The amount of liquid flowing into the treatment device 100 is naturally present under real conditions, but is so small that it can be neglected for the purposes of the present invention.

[0122] In some embodiments, the blood treatment device 100 is calibrated. For this purpose, a predetermined target flow through the dialyzer 303, but in any case a predetermined target temperature TD_ S OII for the temperature of the dialysis fluid or dialysate at the dialyzer 303, or as it flows through it, can be specified. The latter can be stored in a memory device for the control or regulating device 150 or entered by the user, e.g., at the blood treatment device 100.

[0123] After a start-up phase, for example, a first temperature Ti (here by means of the first temperature sensor 165a in the dialysate outlet line 102) and / or a second temperature T2 (here by means of the second temperature sensor 165b in the dialysis fluid inlet line 104) can be determined, e.g. measured. The temperature difference T2-T1 reflects the influence of the ambient conditions, usually the ambient temperature value Tu mg , on the temperature of the dialysis fluid or dialysate.

[0124] In the example of Fig. 2, the measurement is performed without the dialyzer 303. In some embodiments, the measurement can also be performed with the dialyzer 303, but should preferably be performed without a patient, since the patient's blood temperature would falsify the measurement result.

[0125] The measurement described above with a short-circuit cable 350 is the quickest and least critical from a risk-technical point of view, since only the radiation behavior of the hoses is included in the measurement.

[0126] The measurement would be most accurate if the dialyzer 303 were also connected, since its radiation behavior would then also be compensated. This would entail additional effort during the preparation phase, but is also encompassed by the invention.

[0127] Fig. 3 shows a simplified schematic view of a control or regulating device 150 according to the invention with temperature data streams.

[0128] A dialysis fluid flow along the heating device 162, the second temperature sensor 165b, through the dialyzer 303 or the resulting dialysate flow in the direction of the first temperature sensor 165a is represented by a continuous arrow.

[0129] Determined temperatures are represented in the example in Fig. 3 by dash-dot arrows. The values ​​required to determine a deviation of the temperature value T rec h of the relevant or required target temperature TD_ S OII on the dialyzer 303 and / or the one used to determine a deviation of the first temperature value Ti from the target temperature Ti_ so ii required target temperatures TD_ at the first temperature sensor 165a S O1I , T I_ S O II are entered by the user or are stored in a storage device 151 provided for this purpose and can be retrieved from there by the control or regulating device 150.

[0130] In addition to the components of the blood treatment device 100, in the example of Fig. 3, the control or regulating device 150 is also in signal connection with an ambient temperature sensor 165c, which is optionally provided and suitable for measuring the ambient temperature value Tu mgto which the blood treatment device 100 is exposed and to transmit it to the control or regulating device 150. Alternatively, this temperature can be retrieved from the ambient temperature sensor 165c by means of the control or regulating device 150.

[0131] Likewise, the two temperature sensors 165a and 165b, if both are present or required, are directly or indirectly in signal connection with the control or regulating device 150 to determine the temperature values ​​Ti, T2 (see previous figures).

[0132] In the example of Fig. 3, the control or regulating device 150 is configured in one embodiment to calculate the calculated temperature value T rec h at the dialyzer 303. This can be based on the first temperature value Ti and / or on the second temperature value T2 of the first liquid, respectively; it can also be based on the temperature coefficient.

[0133] The calculation of the calculated temperature value T rec h at the blood treatment device or the dialyzer 303 provides an estimate of the actual temperature of the first liquid flowing through the blood treatment device. This knowledge is used to determine a deviation between the estimated temperature at the blood treatment device and its setpoint TD_ S OII is used at this point. The deviation is used to increase or adjust the temperature of the dialysis fluid by means of the heating device 162 based on the deviation of the calculated temperature value T rec h from the setpoint TD_ S O1I TO arrange .

[0134] For example, the influence of the ambient temperature value Tu mg homogeneous .

[0135] If a linear temperature drop is assumed for the respective line length LI, L2 of the line sections, a temperature coefficient Tk in the unit [° C / m] can be defined, for example, as follows:

[0136] (T2 - TI) k LI + L2 ' where :

[0137] TI measured first temperature value from the first temperature sensor 165a downstream of the dialyzer 303

[0138] T2 measured second temperature value from the second temperature sensor 165b upstream of the dialyzer 303 LI length of the line section preferably outside the blood treatment device 100 upstream of the dialyzer 303

[0139] L2 Length of the line section preferably outside the blood treatment device 100 downstream of the dialyzer 303

[0140] If a linear relationship between temperature drop and flow is assumed, then for a reference flow of 500 ml / min:

[0141] 500 ml / min,

[0142] Using the specified formula, the control or regulating device 150 can calculate the temperature coefficient Tk and, based on this, the number of degrees by which the temperature to which the dialysis fluid has previously been brought by the heating device 162 must be adjusted to compensate for the influence of the ambient temperature. This can lead to a reduction or an increase in the heating power.

[0143] For a calculated temperature value T rec h in the dialyzer 303 in one embodiment:

[0144] Trech = T2 — LI * T k or

[0145] Trech — TL + L2 * T k and for the temperature at the first temperature sensor 165a : TI = T2 - ((LI + L2) * T k )

[0146] If, for example, a target temperature in the sense of a "desired temperature" of TD_SO1I = 37 ° C is to prevail for the dialyzer 303, and a temperature value T2 of 37 ° C is measured by the second temperature sensor 165b upstream of the blood treatment unit and a temperature loss of 1 ° C is determined over the lengths LI and L2 of the line sections - here assumed to be of equal length - since the first temperature value TI determined by the first temperature sensor 165a is 35 ° C, then the calculated temperature value T rec h for the dialyzer 303 36 ° C .

[0147] To the di f ference between T rec h and TD_ SO1I, the heating device 162 must be caused to heat the dialysis fluid more strongly by precisely this difference so that the desired 37 ° C is reached in the dialyzer 303. The control or regulating device 150 can be programmed to control or regulate the heating device 162 accordingly.

[0148] However, the example of Fig. 3 discloses a further embodiment in which the control or regulating device 150 is configured to determine the first temperature value Ti of the first liquid by means of the first temperature sensor 165a in order to detect a deviation of the determined temperature value Ti from the setpoint value Ti_ so ii for the target or desired temperature at this point, and to increase or adjust the temperature of the dialysis fluid by means of the heating device 162 based on the deviation between the first temperature value Ti and the target value Ti_ soii . This can be done in the form of a control by determining the first temperature value Ti again after a change in the heating power by the heating device 162 and comparing it with the

[0149] Setpoint Ti_soii is compared, etc. In this procedure, the consideration of an ambient temperature value Tu mg can be omitted, as can the consideration of the second temperature value T2 .

[0150] As can be seen from the above explanations, internal device influences on the temperature, which, for example, affect the dialysis fluid after it flows past the second temperature sensor 165b, are neglected here. This is harmless to a first approximation. However, in embodiments other than those discussed above, such internal device influences are also taken into account. This can be done, for example, when determining the temperature coefficient Tk.

[0151] Values, target values, coefficients and the like disclosed herein can optionally be determined or calculated by the control or regulating device 150 within the scope of the above disclosure, for example by means of a corresponding computing device which is comprised by the control or regulating device 150 or is connected to it. They can alternatively be taken from a storage device 151. These values, target values, coefficients and the like can be stored there after they have first been determined by the control or regulating device 150 or the computing device in a previous step or at an earlier point in time. Although the present invention has been explained here primarily using the example of a blood treatment device which uses a dialyzer for blood treatment, the invention is not limited to this.Their use in other areas of medical technology which do not serve the treatment of kidney-damaged patients is also encompassed by the present invention.

[0152] List of reference symbols

[0153] 100 blood treatment device

[0154] 101 Blood Pump

[0155] 102 Dialysate drain line

[0156] 102a connector

[0157] 104 Dialysis fluid inlet line

[0158] 104a connector

[0159] 105 Substitute management

[0160] 107 Predilution valve

[0161] 107a line belonging to the predilution valve

[0162] 109 Po stdi lut ions ventil

[0163] 109a line belonging to the post-dilution valve

[0164] 111 Substitution pump

[0165] 131 Ultrafiltration pump

[0166] 150 Control or regulating device

[0167] 151 Storage device

[0168] 153 Drain

[0169] 155 Water source

[0170] 157 heat exchangers

[0171] 159 first river pump

[0172] 161 Device for balancing

[0173] 162 Heating device

[0174] 163 Mixing device

[0175] 163a Conductivity sensor

[0176] 163b Conductivity sensor

[0177] 165a first temperature sensor

[0178] 165b second temperature sensor

[0179] 165c ambient temperature sensor

[0180] 166 Concentrate supply

[0181] 167 Leakage sens or

[0182] 168 Concentrate supply 169 second flow pump

[0183] 171 Pump, sodium pump

[0184] 173 Pump, bicarbonate pump

[0185] 300 extracorporeal blood circulation

[0186] 301 first line (arterial line section)

[0187] 302 ( first ) hose clamp

[0188] 303 Blood filter or dialyzer

[0189] 303a Dialysis fluid combs

[0190] 303b Blood chamber

[0191] 303c semi-permeable membrane

[0192] 304a Dialysate port

[0193] 304b Dialysate port

[0194] 305 second line (venous line section)

[0195] 306 (second) hose clamp

[0196] 315 Detector

[0197] 317 Single -Ne noble -Chamber

[0198] 318 venting device

[0199] 319 Detector

[0200] 325 Heparin addition site

[0201] 329 venous blood chamber (optional)

[0202] 350 short-circuit line; short circuit

[0203] 360 housing wall

[0204] Fl Filter

[0205] F2 filter

[0206] A container; A concentrate; sodium

[0207] B container; B concentrate; bicarbonate

[0208] K Compressed air source, compressor

[0209] LI Length of the first line section

[0210] L2 Length of the second pipe section P Pressure measuring points

[0211] PS I arterial pressure sensor (optional)

[0212] PS2 arterial pressure sensor (optional)

[0213] PS3 pressure sensor (optional)

[0214] PS4 pressure sensor for measuring the filtrate pressure

[0215] (optional)

[0216] PS5 pressure sensor for measuring the pressure in the

[0217] Dialyzed fluid is added

[0218] Ti first temperature value

[0219] T2 second temperature value

[0220] TD temperature in the dialyzer

[0221] Tk temperature coefficient

[0222] Trech calculated temperature value

[0223] TD_SO1I Setpoint for the temperature at the

[0224] Blood treatment facility

[0225] Ti_soii Setpoint for the temperature at the first

[0226] Temperature sensor

[0227] Tumg ambient temperature value

[0228] V valves

[0229] V24 valve

[0230] V25 valve

[0231] VB bypass valves

[0232] Y Y-connector

Claims

Claims 1. A control or regulating device (150) configured to control or regulate the operation of a blood treatment device (100) for treating a patient during a blood treatment session, in which the blood treatment device (100) is connected to an extracorporeal blood circuit (300) and a blood treatment device, e.g., a dialyzer (303) or blood filter, and wherein or when the blood treatment device (100) further comprises: - a dialysis fluid supply line (104) and a dialysate outlet line (102) arranged to supply and discharge dialysis fluid to and from the blood treatment device (303) during the blood treatment session; - a heating device (162) for heating the dialysis fluid before or during the blood treatment session; - one or more temperature sensors (165a, 165b), of which at least a first temperature sensor (165a) is arranged downstream of the blood treatment device and / or downstream of the dialysis fluid supply line (104), for determining a first temperature value (Ti) of a first fluid previously guided along the dialysis fluid supply line (104); wherein the control or regulating device (150) is configured to increase or adjust the temperature of the dialysis fluid by means of the heating device (162) based on the first temperature value (Ti) determined by the first temperature sensor (165a).

2. Control or regulating device (150) according to claim 1, configured to increase or adjust the temperature by means of the heating device (162) additionally based on a second temperature value (T2) which is or was determined by means of a second temperature sensor (165b) of the plurality of temperature sensors (165a, 165b) on the first liquid upstream of the blood treatment device and / or upstream of the dialysate drain line (102).

3. Control or regulating device (150) according to one of the preceding claims, wherein the first and / or the second temperature value (Ti, T2) are or were determined before the start of the blood treatment session.

4. Control or regulating device (150) according to one of the preceding claims, wherein the first and / or the second temperature value (Ti, T2) are or were determined during the blood treatment session.

5. Control or regulating device (150) according to one of the preceding claims, wherein the first or the second temperature value (Ti, T2) are or were determined while the dialysis fluid inlet line (104) and the dialysate outlet line (102) are closed with the exclusion of or are or were fluidly connected to each other, bypassing the blood treatment facility.

6. Control or regulating device (150) according to one of the preceding claims, wherein the first and / or the second temperature value (Ti, T2) are or were determined while the dialysis fluid inlet line (104) and the dialysate outlet line (102) are not or were not arranged excluding or bypassing the blood treatment device.

7. Control or regulating device (150) according to claim 6, wherein during or for determining the first and / or the second temperature value (Ti, T2) no two mutually different liquids have flowed through the blood treatment device or were present therein.

8. Control or regulating device (150) according to one of the preceding claims, wherein a deviation of the first temperature value (Ti) of the first liquid from a setpoint value (Ti_ so ii) for the temperature at the first temperature sensor (165a) is determined.

9. Control or regulating device (150) according to one of the preceding claims, configured, - to be based on both the first temperature value (Ti) as well as on the second Temperature value (T2) of the first liquid a calculated temperature value (T rec h) to calculate; - to avoid a deviation of the calculated temperature value (T rech) at the blood treatment facility from a target value (TD_SO1I) ZU determined; and - to increase or adjust the temperature of the dialysis fluid by means of the heating device (162) based on the deviation of the calculated temperature value (T rec h) based on the setpoint (TD_SOII).

10. Control or regulating device (150) according to claim 9, wherein the calculated temperature value (T rech) is or has been determined at the blood treatment device based on the first and / or the second temperature value (Ti, T2) and a temperature coefficient (Tk), wherein the temperature coefficient (Tk) is or has been determined for the dialysis fluid inlet line (104), or a first line section running in particular outside the blood treatment device (100), in particular its length (L1), and / or for the dialysate outlet line (102), or a second line section running in particular outside the blood treatment device (100), in particular its length (L2).

11. Control or regulating device (150) according to claim 10, configured to determine the temperature coefficient (Tk).

12. Control or regulating device (150) according to one of claims 10 or 11, configured to determine the temperature coefficient (Tk) related to one, two or more flow velocities (Qi, Q2, Q3) of the first fluid through the blood treatment device, or through a short circuit of the dialysis fluid inlet line (104) and the dialysate outlet line (102) excluding or bypassing the blood treatment device, or in each case into it.

13. Control or regulating device (150) according to one of claims 8 to 12, configured to adjust the temperature of the dialysis fluid, to which the dialysis fluid is brought during or before the blood treatment session by means of the heating device (162), by the difference between the first temperature value (Ti) and the setpoint value (Ti_ so ii) for the first temperature, or by the difference between the calculated temperature value (T rec h) and the Setpoint (TD_SO1I) for the temperature at the blood treatment device, or at least by this difference, to increase or decrease.

14. Control or regulating device (150) according to one of the preceding claims, wherein the first temperature value (Ti) is determined only downstream of the blood treatment device.

15. Control or regulating device (150) according to one of the preceding claims, configured to increase or adjust the temperature to which the dialysis fluid is heated during or before Blood treatment session is brought by means of the heating device (162), further the ambient temperature value (Tu mg ) must be taken into account.

16. Blood treatment device (100) prepared for use with an extracorporeal blood circuit (300) and a blood treatment device, e.g. Dialyzer (303) or blood filter for treating the blood of a patient during a blood treatment session, comprising - at least one receptacle for detachably receiving at least a portion of the extracorporeal blood circuit (300) on the blood treatment device (100); - at least one receptacle for releasably receiving at least a portion of the blood treatment device on the blood treatment apparatus (100); - a dialysis fluid supply line (104) and a dialysate outlet line (102) arranged to supply and discharge dialysis fluid to and from the blood treatment device (100) or a receptacle therefor during the blood treatment session; - one or more temperature sensors (165a, 165b), of which at least a first temperature sensor (165a) is located downstream of the Blood treatment device and / or downstream of a dialysis fluid supply line (104), for determining a first temperature value (Ti) of a first fluid flowing through the dialysis fluid supply line (104) or resting therein; a heating device (162) for heating the dialysis fluid before or during the blood treatment session; - a control or regulating device (150) according to one of the preceding claims for controlling or regulating the operation of the blood treatment device (100).

17. The blood treatment device (100) according to claim 16, further comprising 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 drain line (102).

18. Blood treatment device (100) according to one of claims 16 or 17, further comprising or connected to an ambient temperature sensor (165c) for determining an ambient temperature value (Tu mg ) .

19. Blood treatment device (100) according to one of claims 16 to 18, designed as a dialysis device, hemodialysis device, hemofiltration device or Hemodiafiltration device, in particular as a device for acute, chronic renal replacement therapy or for continuous Renal replacement therapy (CRRT = continuous renal replacement therapy).

20. Digital storage medium, in particular in the form of a floppy disk, memory card, CD or DVD, EPROM, FRAM or SSD, with electronically readable control signals, configured to interact with a programmable computer system in such a way that a conventional control or regulating device is reprogrammed into a control or regulating device (150) according to one of claims 1 to 15 and / or a conventional blood treatment device is reprogrammed into a blood treatment device (100) according to one of claims 16 to 19.

21. Computer program product, as a signal wave or with a program code stored on a machine-readable carrier, in order to interact with a programmable computer system in such a way that a conventional control or regulating device is reprogrammed into a control or regulating device (150) according to one of claims 1 to 15 and / or a conventional blood treatment device is reprogrammed into a blood treatment device (100) according to one of claims 16 to 19.

22. Computer program with a program code that a conventional control or regulating device is reprogrammed into a control or regulating device (150) according to one of claims 1 to 15 and / or a conventional blood treatment device is reprogrammed into a blood treatment device (100) according to one of claims 16 to 19 when the computer program runs on a computer.

Images