Blood treatment device that compensates for ambient temperature changes

Abstract

The present invention relates to a control device or closed-loop control device (150) configured to control or in a closed-loop manner the operation of a blood treatment apparatus (100) for treating a patient during a blood treatment session, the blood treatment apparatus (100) being connected to an extracorporeal blood circuit (300) and a blood treatment device, such as a dialyzer (303) or a blood filter. The blood treatment apparatus (100) further comprises a dialysate inlet line (104) and a dialysate effluent outlet line (102), a heating device (162) for heating the dialysate, and one or several temperature sensors (165a, 165b), at least a first temperature sensor (165a) of which is arranged downstream of the blood treatment device and / or downstream of the dialysate inlet line (104) for determining a first temperature value (T1) of a first liquid previously advanced along the dialysate inlet line (104). Here, the control device or closed-loop control device (150) is configured to increase or set the temperature of the dialysate using the heating device (162) based on a first temperature value (T1) determined by a first temperature sensor (165a).

Description

[Technical Field]

[0001] The present invention relates to a control device or closed-loop control 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 according to each of the preambles or generic titles of these claims, respectively. [Background technology]

[0002] Known in practice are blood treatment devices that administer a treatment liquid to a patient by means of a pump, often via an extracorporeal blood circuit, as in the case of a dialysis device. In blood treatment devices such as dialysis devices, the treatment liquid is additionally or alternatively supplied, for example, to a blood filter through which the blood flows. Since the temperature of the treatment liquid delivered in both of the above cases can affect the temperature of the blood reinfused into the patient, a heating device can be provided to heat or regulate the treatment liquid. Summary of the Invention

[0003] It is an object of the present invention to define a further control or closed-loop control device and a further blood treatment apparatus.A digital storage medium, a computer program product and a computer program are also defined.

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

[0005] The present invention relates to a control device or closed-loop control device configured to control or control in a closed-loop manner the operation of a blood treatment apparatus for treating a patient during a blood treatment session, the blood treatment apparatus being 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 includes a dialysate inlet line configured to supply dialysate to the blood treatment device during a blood treatment session, and a dialysate outlet line configured to drain dialysate effluent, i.e., spent dialysate, from the blood treatment device during a blood treatment session.

[0007] A heating device for heating the dialysate before or during the blood treatment session is also included in the blood treatment machine.

[0008] The blood treatment device further comprises one or several temperature sensors, which may be temperature gauges or devices from which the temperature can be estimated.

[0009] At least a first of these temperature sensors, located downstream of the blood treatment device and / or downstream of the dialysate inlet line, functions to determine a first temperature value of a first liquid previously advanced along the dialysate inlet line toward the blood treatment device.

[0010] In this case, the control device or closed-loop control device is configured to increase or set the temperature of the dialysate by the heating device based on a first temperature value determined by the first temperature sensor.

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

[0012] A blood treatment device according to the present invention comprises at least one receptacle for releasably receiving at least one section of an extracorporeal blood circuit on the blood treatment device.

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

[0014] The blood treatment apparatus according to the present invention further comprises a dialysate inlet line configured to supply dialysate to the blood treatment device during a blood treatment session, and a dialysate outlet line configured to drain dialysate effluent, i.e., spent dialysate, from the blood treatment device during a blood treatment session.

[0015] The device further includes one or several temperature sensors, which may be temperature gauges or devices for estimating temperature. At least a first of these temperature sensors is located downstream of the blood treatment device and / or downstream of the dialysate inlet line. It serves to determine a first temperature value of a first liquid flowing through or in the dialysate inlet line.

[0016] A heating device, which serves to heat the dialysate before or during the blood treatment session, is also included in the blood treatment apparatus according to the present invention.

[0017] The blood treatment apparatus according to the invention further comprises a control device or a closed-loop control device according to the invention, by means of which the operation of the blood treatment apparatus can be controlled or controlled in a closed-loop manner.

[0018] A digital storage medium, in particular a non-volatile storage medium, according to the invention, in particular having electronically or optically readable control signals, in particular in the form of a machine-readable carrier, in particular in the form of a diskette, memory card, CD, DVD, EPROM, FRAM (Ferroelectric RAM) or SSD (Solid-State-Drive), can interact with a programmable computer system so that a conventional control device or closed-loop control device is reprogrammed into a control device or closed-loop control 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 present invention comprises volatile or transitory program code or program code stored on a machine-readable carrier or signal wave, which, when the computer program product is run on a computer, reprograms a conventional control device or closed-loop control device into a control device or closed-loop control device according to the present invention. Alternatively or additionally, a conventional blood treatment apparatus is reprogrammed into a blood treatment apparatus according to the present invention.

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

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

[0022] The computer program according to the invention comprises program code which, when the computer program is run on a computer, causes a conventional control device or closed-loop control device to be reprogrammed into a control device or closed-loop control device according to the invention. Alternatively or additionally, a conventional blood treatment apparatus is reprogrammed into a blood treatment apparatus according to the invention.

[0023] An embodiment according to the invention may comprise one, some or all of the features described below in any combination, unless a person skilled in the art would consider a particular combination to be technically impossible.

[0024] In all of the foregoing and following descriptions, the use of expressions such as "may" or "may have" should be understood to be synonymous with "preferably is" or "preferably has", respectively, and is intended to exemplify embodiments in accordance with the present invention.

[0025] Whenever numerical terms are referred to herein, those skilled in the art will recognize or understand them as indicators of a lower numerical limit. Thus, unless this creates a clear contradiction for those skilled in the art, those skilled in the art will understand, for example, "one" (or "a / an") as encompassing "at least one." This understanding is also equally encompassed by the present invention, as is the interpretation that a numerical term such as "one" (or "a / an") can alternatively mean "exactly one," whenever this is clearly technically possible from the perspective of those skilled in the art. Both of these understandings are encompassed by the present invention and apply to all numerical terms used herein.

[0026] Those skilled in the art will understand spatial information such as, for example, "top," "bottom," "left," or "right," whenever referenced herein, as spatial designations with reference to the orientation in and / or in use of the figures attached hereto, with "bottom" being closer to the center of the earth or the lower edge of the figure than "top."

[0027] When reference is made herein to "determining," particularly determining data and / or temperature values, this may be or include examining for presence or absence, measuring, setting, detecting, recording, collecting, evaluating, processing, comparing, estimating, ranking or assessing, inferring, calculating, obtaining, arriving at or achieving, and / or recognizing.

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

[0029] Whenever an embodiment is referred to herein, it represents an exemplary embodiment according to the present invention, which should not be understood as limiting.

[0030] If the subject matter according to the invention is disclosed herein as comprising one or several features in certain embodiments, it is also hereby respectively disclosed that the subject matter according to the invention, in other embodiments as well as in accordance with the invention, does not explicitly comprise this or these features, e.g., in the sense of exclusion. Thus, for every embodiment mentioned herein, it applies that the opposite embodiment, e.g., formulated as a negation, is also disclosed.

[0031] When reference is made herein to programming or configuring, these terms may be interchangeable in some embodiments.

[0032] When a signal communication or communication connection between two components is referred to herein, this may be understood to mean the connection that exists during use. It may also be understood that provisions for such signal communication (whether wired, wireless, or otherwise implemented) exist, for example, by coupling both components, for example, by pairing, etc.

[0033] Pairing is a process carried out in connection with computer networks to establish an initial link between computer units for the purpose of communication. The best-known example of this is the establishment of a Bluetooth® connection, where various devices (e.g., smartphones, headphones) are connected to each other. Pairing is sometimes also called bonding.

[0034] A control device or closed-loop control device may prompt all or substantially all of the method steps to be performed. The method according to the invention may be substantially or completely performed by a control device. It may also be partially performed by a control device, in particular steps that do not require or involve human intervention and / or provision may be performed by a control device. The control device may be used purely as a control device or as a closed-loop control device.

[0035] In some embodiments, the control device or closed-loop control device resides within or on the blood treatment apparatus, for example, within a common housing of the blood treatment apparatus with other components or devices of the blood treatment apparatus.

[0036] In some embodiments, a control device or closed-loop control device according to the present invention is configured to increase or set the temperature by the heating device further based on a second temperature value, which may be or has been determined by a second temperature sensor of a plurality of temperature sensors on the first fluid upstream of the blood treatment device and / or upstream of the dialysate effluent outlet line.

[0037] In some embodiments, the first and / or second temperature values ​​are or were determined before the start of the blood treatment session.

[0038] The first and / or second temperature values ​​may be stored in the control device or closed-loop control device or in a storage device suitable or provided for this purpose.

[0039] In some embodiments, the first and / or second temperature values ​​are or were determined during a blood treatment session.

[0040] In some embodiments, the first or second temperature value, respectively, is or was determined while the dialysate inlet line and the dialysate effluent outlet line are or were connected in fluid communication with each other, for example, by a shunt line that excludes or bypasses the blood treatment device.

[0041] In some embodiments, the first and / or second temperature values ​​are or were determined while the dialysate inlet line and the dialysate outlet line are or are not positioned to exclude or bypass the blood treatment device and are respectively connected, e.g., in fluid communication, to the blood treatment apparatus.

[0042] In some embodiments of the control device or closed-loop control device according to the invention, when or for determining the first and / or second temperature values, no two different liquids flow through or are present in the blood treatment device, and in particular, no blood as the second liquid flows therein.

[0043] In some embodiments of the control device or closed loop control device, the deviation of a first temperature value of a first liquid from a set point for that liquid at this time is determined.

[0044] In some embodiments of the control device or closed-loop control device, the control device or closed-loop control device is configured to calculate a calculated temperature value based on both the first temperature value and the second temperature value of the first fluid to determine a deviation of the calculated temperature value at the blood treatment device from a temperature setpoint at this time and prompt the heating device to increase or set the dialysate temperature based on the deviation of the calculated temperature value at the blood treatment device from the setpoint of the blood treatment device.

[0045] In some embodiments, the setpoint temperature for the temperature value at the dialyzer required to determine the deviation of the temperature value at the dialyzer from the temperature value at the dialyzer and / or the setpoint temperature for the temperature value at the first temperature sensor required to determine the deviation of the measured first temperature value from the setpoint temperature at the first temperature sensor are input by a user, for example, via an input interface of the blood treatment device. Alternatively, these setpoint temperatures can be stored in a memory device provided for this purpose and retrieved therefrom by the control device or closed-loop control device.

[0046] In some embodiments, the calculated temperature value in the blood treatment device is, or was determined or calculated based on the first and / or second temperature values ​​and a temperature coefficient determined for the dialysate inlet line, or particularly for a first line segment extending particularly over its length outside the blood treatment apparatus, and / or for the dialysate effluent outlet line, or particularly for a second line segment extending particularly over its length outside the blood treatment apparatus.

[0047] The calculation of the calculated temperature value at the blood treatment device or dialysis machine provides an estimate of the actual temperature of the first fluid as it flows through the blood treatment device. This can be used to determine the deviation between the estimated temperature at the blood treatment device and its setpoint at this time. The deviation, in accordance with the present invention, is used to prompt the heating device to increase or set the dialysate temperature based on the deviation of the calculated temperature value from its setpoint.

[0048] where the following is the calculated temperature value T of the dialyzer in one embodiment: rech , i.e.,

[0049]

number

[0050] or

[0051]

number

[0052] and the temperature at the first temperature sensor, i.e.,

[0053]

number

[0054] applies to.

[0055] In some embodiments, the control device or closed loop control device has a temperature coefficient T k is configured to determine

[0056] If a linear temperature drop is assumed for each line length L1 and L2 of the line segment, the temperature coefficient T in °C / m is k can be defined for these as follows, for example:

[0057]

number

[0058] In this regard, the following applies: T1: First temperature value measured from a first temperature sensor downstream of the dialyzer T2 is a second temperature value measured from a second temperature sensor upstream of the dialyzer. L1: Length of the line segment, preferably outside the blood treatment device, upstream of the dialyzer L2: Length of the line segment, preferably outside the blood treatment device downstream of the dialyzer In some embodiments, the control device or closed-loop control device is configured to determine a temperature coefficient for one, two, or more, particularly predetermined, flow rates of the first liquid into or through the blood treatment device. Alternatively, the temperature coefficient is or has been determined for one, two, or more, particularly predetermined, flow rates of the first liquid, respectively, within a shunt between the dialysate inlet line and the dialysate effluent outlet line, e.g., within a shunt line, excluding or bypassing the blood treatment device.

[0059] If a linear relationship between temperature drop and flow rate is assumed, the following applies for a reference flow rate of 500 ml / min:

[0060]

number

[0061] Ambient temperature value T Umg The effects of are assumed to be uniform in these calculations in certain embodiments.

[0062] In some embodiments, the control device or closed-loop control device according to the present invention is configured to increase or decrease the temperature of the dialysate heated using 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 temperature set point at those points, respectively.

[0063] In some embodiments of the control device or closed-loop control device, only a first temperature value downstream of the blood treatment device is determined.

[0064] In some embodiments, the control device or closed-loop control device is configured to further take into account the determined ambient temperature value when increasing or setting the temperature to which the dialysate is heated by the heating device during or before the blood treatment session. The ambient temperature value may be or has been determined, for example, by an ambient temperature sensor, e.g., a temperature sensor of the blood treatment machine.

[0065] In some embodiments, the blood treatment apparatus according to the present invention further comprises a second temperature sensor of 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 effluent outlet line.

[0066] In some embodiments, the blood treatment device further comprises or is connected to an ambient temperature sensor, the ambient temperature sensor being suitable for and / or provided to determine an ambient temperature value of the blood treatment device.

[0067] In one embodiment, the ambient temperature sensor may be in signal communication with a control device or closed-loop control device and transmit the measured ambient temperature value thereto. Alternatively, a control device or closed-loop control device may be used to obtain this temperature value from the ambient temperature sensor.

[0068] In some embodiments, the blood treatment device is embodied as a dialysis device, a hemodialysis device, a hemofiltration device, or a hemodiafiltration device, particularly as a device for acute renal replacement therapy, chronic renal replacement therapy, or continuous renal replacement therapy (CKRT).

[0069] In some embodiments, the present invention is not limited to the use of blood treatment devices that use dialyzers for blood treatment, but also encompasses its use in other areas of medical technology that do not lend themselves to treating renal failure patients.

[0070] In some embodiments, additional internal device effects, particularly temperature effects, are included in the calculations described herein, while in other embodiments they are ignored. Such considerations can include, for example, the temperature coefficient T k Therefore, a series of temperature coefficients T k may be determined respectively at different predetermined environmental conditions and in particular environmental temperatures and may optionally be stored, for example in a storage device.

[0071] In some embodiments, the values, set points, coefficients, etc. disclosed herein may optionally be determined or calculated by a control device or closed-loop control device within the scope of the present disclosure, for example, by a corresponding computing device included in or connected to the control device or closed-loop control device. They may, in each case, alternatively be retrieved by the latter from a storage device, where these values, set points, coefficients, etc. may be stored after having been initially determined by the control device or closed-loop control device or computing device at a previous step or time.

[0072] When a method step is referred to herein, in some embodiments it is provided that it occurs before or after treatment of the patient, such as while the patient is not connected to the device, e.g., via an extracorporeal blood circuit, or when treatment has not yet begun or has already ended.

[0073] In some embodiments, the patient's body temperature and / or temperatures correlated thereto are not measured or determined, and / or temperature sensors are not positioned for this purpose. In some embodiments, the body temperature is not included in or controlled by calculations or decisions performed or initiated by the control device or closed-loop control device or other components.

[0074] In some embodiments, the control device or closed-loop device does not take into account the patient's body temperature and / or temperatures correlated thereto when adjusting or increasing the temperature of the dialysate using a heating device or for that matter.

[0075] In some embodiments, neither the calculations or decisions performed or initiated by the control device or closed-loop control device, or by another component, nor the control take into account variables that are variable characteristics of heat transfer through the dialysis machine.

[0076] Some or all embodiments according to the present invention may have one, some or all of the above and / or following advantages.

[0077] One advantage of the present invention is that the heating power of the heating device can be controlled based on temperature, thereby ensuring that the temperature at a given point does not exceed a maximum temperature and / or does not fall below a set point temperature. With respect to the aforementioned temperature values, the corresponding adjustment of the pump delivery speed for delivering the treatment liquid can be omitted, and the patient can be protected from the consequences of using a treatment liquid with an inappropriate temperature.

[0078] According to the invention, the temperature at the temperature sensor or the heat loss of the treatment liquid between the first and second temperature sensors can be determined by simple means and is therefore known, and therefore the temperature difference can advantageously be detected and the heating device can be controlled accordingly in a closed-loop manner.

[0079] Another advantage of the present invention may be that existing systems may be easily retrofitted with software updates, since existing sensors of the blood treatment device and their control devices or closed-loop control devices may be used.

[0080] The invention will now be described, by way of example only, with reference to the accompanying drawings, in which like reference symbols indicate identical or similar elements, and in which: [Brief explanation of the drawings]

[0081] [Figure 1] 1 is a simplified schematic diagram of a fluid line diagram of a blood treatment device according to the present invention in a first embodiment; [Figure 2] FIG. 2 shows a portion of the fluid line diagram of FIG. 1 in which a short circuit line connects the dialysate inlet line and the dialysate waste outlet line together instead of the blood treatment device. [Figure 3] 1 shows a simplified schematic diagram of a control device or closed-loop control device according to the invention having a temperature data stream; DETAILED DESCRIPTION OF THE INVENTION

[0082] Figure 1 shows a fluid line diagram of a blood treatment device 100 according to the present invention in a first embodiment, in which the blood treatment device is represented in part by only a single highly schematic simplified component.

[0083] The blood treatment device 100, shown in an at least partially equipped state of use, is connected to an extracorporeal blood circuit 300, which may be connected for treatment to the patient's vascular system, not shown, by dual needle access or by single needle access, for example when using an additional Y-connector (reference Y) as shown in Figure 1, said extracorporeal blood circuit 300 being optionally not part of the blood treatment device 100, although in other embodiments it is part of the blood treatment device 100. The blood circuit 300 may optionally be present in or on a blood cassette.

[0084] Pumps, actuators and / or valves in the area of ​​the blood circuit 300 are connected in signal communication to the blood treatment device 100 according to the present invention or to a control device or closed-loop control device 150, respectively, and are encompassed thereby, e.g., if control or control in a closed-loop manner is required.

[0085] The blood circuit 300 comprises (or is connected to) an arterial section, or arterial patient line, blood collection line or first line 301, an arterial patient tubing clamp 302 and an arterial connecting needle (not shown in FIG. 1).

[0086] The blood circuit 300 also includes (or is connected to) a venous section, a venous patient line, a venous patient tubing clamp 306 of the blood return line or second line 305 and a venous connection needle (not shown in FIG. 1).

[0087] The blood pump 101 is provided in or on the first line 301, and an optional replacement fluid pump 111 is connected to the dialysate inlet line 104 for transporting fresh dialysate (replacement fluid) that is filtered, for example, in a filtration step (filter F2).

[0088] The optional substitution fluid line 105 may be fluidly connected, for example, to the dialysate inlet line 104. Using the substitution fluid pump 111, substitution fluid may be introduced by pre-dilution via the optional pre-dilution valve 107 or by post-dilution via the optional post-dilution valve 109 via the optional associated line 107a or 109a into a line section, for example, the arterial line section 301 or the venous line section 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 trap 329).

[0089] The hemofilter 303 comprises a blood chamber 303b connected to the arterial line section 301 and the venous line section 305. The dialysate chamber 303a of the hemofilter 303 is connected to a dialysate inlet line 104 leading to the dialysate chamber 303a and to a dialysate effluent outlet line 102 conducting the dialysate effluent, i.e., the spent dialysate, leaving the dialysate chamber 303a. Suitable connectors 104a, 102a on the dialysate inlet line 104 or the dialysate effluent outlet line 102 on the one hand and the dialysate effluent ports 304a, 304b of the hemofilter 303 on the other hand can be particularly releasably connected to each other and serve for this purpose.

[0090] The dialysate chamber 303a and the blood chamber 303b are separated from one another by a mostly semi-permeable membrane 303c, which represents the partition between the blood side, which contains the extracorporeal blood circuit 300, and the machine side, which contains the dialysate or dialysate drain circuits, and is shown to the left of membrane 303c in FIG.

[0091] The configuration of Figure 1 includes an optional detector 315 for detecting air and / or blood. The configuration of Figure 1 optionally further includes one or two pressure sensors PS1 (upstream of blood pump 101) and PS2 (measuring pressure downstream of blood pump 101, upstream of blood filter 303 ("pre-blood filter")) at the points shown in Figure 1. Additional pressure sensors may be provided, such as pressure sensor PS3 downstream of venous bubble trap 329.

[0092] The optional single-needle chamber 317 is used as a buffer container and / or compensation reservoir in single-needle procedures where the patient is connected to the extracorporeal blood circuit 300 using only one of the two blood lines 301, 305 in FIG.

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

[0094] 1, an optional mixing device 163 is shown, which provides a predetermined mixture for each solution from containers A (for A concentrate via concentrate supply 166) and B (for B concentrate via concentrate supply 168) for use by blood treatment apparatus 100. The solutions contain water from water source 155 (online, e.g., as reverse osmosis water or from a bag), which is heated, e.g., in 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 conveys from the mixing device 163 and a sodium source, such as vessel A. An optional pump 173 associated with vessel B, such as for bicarbonate, may be identified.

[0096] 1 further shows a drain 153 for waste liquid. An optional heat exchanger 157 and an optional first flow pump 159 suitable for degassing complete the arrangement shown.

[0097] The optional pressure sensor PS4 may be provided downstream of the blood filter 303 on the water side, but preferably upstream of the optional ultrafiltration pump 131 in the dialysis effluent outlet line 102 to measure the filtrate pressure or membrane pressure of the blood filter 303.

[0098] The ultrafiltration pump 131 provides a means for removing a precise volume of fluid from the balancing circuit as specified by the user and / or the control device or closed-loop control device 150 .

[0099] Blood exiting the hemofilter 303 flows through an optional venous bubble trap 329, which may be equipped with a degasser 318 and may be in fluid communication with a pressure sensor PS3.

[0100] 1 comprises a control device or closed-loop control device 150 according to the present invention, which may be in wired or wireless signal connection with any of the components mentioned herein, in particular or specifically with the blood pump 101, for controlling or controlling the blood treatment apparatus 100 in a closed-loop manner.

[0101] By using a device for online mixing of the dialysate, fluctuations in its sodium content are possible within certain limits, which are controlled by the control device or closed-loop control device 150. For this purpose, in particular, the measured values ​​determined by the conductivity sensors 163a, 163b can be taken into account. If it turns out that an adjustment of the sodium content of the dialysate (sodium concentration) or substitution fluid is necessary or desirable, this can be done by adjusting the delivery speed of the sodium pump 171.

[0102] Furthermore, the treatment apparatus 100 includes devices for transporting fresh dialysate and dialysis effluent. An optional first valve V24 may be provided between the first flow pump 159 and the hemofilter 303, and the first valve V24 opens and closes the inflow toward the hemofilter 303 on the inlet side. A second optional flow pump 169 that transports the dialysis effluent to the drain 153 is provided, for example, downstream of the hemofilter 303. A second valve V25 may be provided between the hemofilter 303 and the second flow pump 169, and the second valve V25 opens and closes the outflow on the outlet side.

[0103] Additionally, blood treatment apparatus 100 optionally includes a device 161 for balancing the flows into and out of machine-side dialyzer 303. Balancing device 161 is preferably located in the line section between first flow pump 159 and second flow pump 169.

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

[0105] The temperature sensors, including the first temperature sensor 165a and / or the second temperature sensor 165b, may be provided singly or in groups, and the temperature values ​​provided by them may be used to determine a temperature-compensated conductivity during a patient's treatment, to determine at least one temperature value of the dialysis effluent (downstream of the dialyzer 303) and / or at least one temperature value of the dialysate (upstream of the dialyzer 303) during a blood treatment, or, according to the present invention, to determine at least a first temperature value T1 of the liquid exiting downstream of the dialyzer (which may be referred to as dialysis effluent during a blood treatment, also performed in accordance with the present specification) and / or at least a second temperature value T2 of the liquid entering upstream of the dialyzer (which may be referred to as dialysate during a blood treatment, also performed in accordance with the present specification).

[0106] A leak sensor 167 is optionally provided and can be provided in different locations.

[0107] For example, in addition to or instead of the flow pump having reference numeral 169, further flow pumps may be provided.

[0108] Some optional valves are each designated V in FIG. 1, and the bypass valve is designated VB.

[0109] A pressure sensor P25 may be provided to measure the pressure in the dialysate inlet line 104.

[0110] The control device or closed-loop control device 150, in some embodiments, determines electrolyte balance and / or fluid balance based on measurements from the optional sensors mentioned above.

[0111] The filters F1 and F2 may be provided connected in series.

[0112] Even when non-pure water is used, the filter F1 functions, as an example herein, to produce a sufficiently pure dialysate by means of the mixing device 163, which then flows through the hemofilter 303, for example using the countercurrent principle.

[0113] Filter F2 serves here illustratively to produce a sterile or sufficiently filtered substitution fluid from the sufficiently pure dialysate exiting first filter F1, for example by filtering out pyrogens, which substitution fluid can then be safely added to the blood flowing outside the patient's body and ultimately added to the patient's body.

[0114] An optional ambient temperature sensor 165c, which may be part of the blood treatment device 100, detects an ambient temperature value T Umg (See FIG. 3). The control device or closed-loop control device 150 may use this determined ambient temperature value T Umg may be configured to further consider

[0115] The ambient temperature sensor 165 c may also be provided separate from the blood treatment apparatus 100 but still in signal communication with its control device or closed-loop control device 150 .

[0116] Although blood treatment device 100 is optionally shown in FIG. 1 as a device for hemo(dia)filtration, hemodialysis devices are nevertheless also covered by the present invention, even though they are not specifically shown in the figures.

[0117] The arrows shown in FIG. 1 generally indicate the direction of flow in FIG.

[0118] 2 shows a portion of the fluid line diagram of FIG. 1, where instead of the blood treatment device 303, a shunt 350 connects the dialysate inlet line 104 and the dialysate effluent outlet line 102, which corresponds to bypassing the blood filter 303. Such a shunt can be used, for example, before the next blood treatment, to first check all relevant components of the blood treatment apparatus 100 for their functionality.

[0119] See the description of FIG.

[0120] In the example of FIG. 2, the dialyzer or blood filter 303, along with the extracorporeal blood circuit 300 and its pumps, actuators and / or valves, is shown in an unequipped state and therefore separate from the hydraulic system of the blood treatment device 100.

[0121] The housing wall 360 of the blood treatment device 100 is shown with double lines. In accordance with the present invention, it is assumed that the temperature of the dialysate or dialysate effluent inside the blood treatment device 100 (i.e., to the left of the housing wall 360) does not change, but the dialysate or dialysate effluent is exposed to ambient temperature along a tubing line or line segment extending for a determinable length L1, L2 outside the blood treatment device 100 (to the right of the housing wall 360 in FIG. 2). The ambient temperature may result in changes in the temperature of the dialysate or dialysate effluent. Changes in the temperature of the dialysate within the treatment device 100 (i.e., the liquid flowing toward or into the dialyzer) naturally occur under real-world conditions, but are so slight as to be negligible for the purposes of the present invention.

[0122] In some embodiments, the blood treatment device 100 is calibrated. To this end, optionally, a predetermined setpoint flow rate through the dialyzer 303 is specified, but in any case, a predetermined setpoint temperature T for the temperature of the dialysate or dialysate effluent at or as it flows through the dialyzer 303. D_soll The latter may be stored in a storage device for the control device or closed-loop control device 150, or may be entered by a user on the blood treatment machine 100, for example.

[0123] After the start-up phase, for example, a first temperature T1 (here, by a first temperature sensor 165a in the dialysate effluent outlet line 102) and / or a second temperature T2 (here, by a second temperature sensor 165b in the dialysate inlet line 104) can be determined, e.g., measured. The temperature difference T2-T1 is the ratio of the environmental conditions, typically an ambient temperature value T, to the temperature of the dialysate or dialysis effluent. Umg Reflects the impact of

[0124] 2, the calibration is performed without the dialyzer 303. In some embodiments, the calibration can also be performed with the dialyzer 303, but preferably should be performed without the patient, as the patient's blood temperature will skew the measurement results.

[0125] Calibration using the short circuit wire 350 described above is the fastest and, from a risk point of view, the least dangerous, since here only the radiation behavior of the tube is included in the measurement.

[0126] If the dialyzer 303 is also connected, its radiation pattern is also compensated, so that the measurement is most accurate. This means additional work during the preparation phase, but is likewise encompassed by the present invention.

[0127] FIG. 3 shows in a simplified schematic form a control device or closed-loop control device 150 according to the invention having a temperature data stream.

[0128] The flow of dialysate through the dialyzer 303 along the heating device 162, the second temperature sensor 165b, or the resulting flow of dialysate effluent towards the first temperature sensor 165a is indicated by continuous arrows.

[0129] The determined temperatures are represented by dashed arrows in the example of FIG.

[0130] The relevant or required set point temperature T in the dialyzer 303 D_soll Temperature value T from rech and / or the setpoint temperature T at the first temperature sensor 165a. 1_soll The setpoint temperature T required to identify the deviation of the first temperature value T1 from D_soll , T 1_soll may be entered by a user or stored in a storage device 151 provided for this purpose and retrieved therefrom by the control device or closed-loop control device 150.

[0131] In addition to the components of the blood treatment apparatus 100, in the example of FIG. 3, a control device or closed-loop control device 150 is optionally provided to control the ambient temperature value T Umg and transmits this value to the control device or closed-loop control device 150. Alternatively, this temperature may be obtained by the control device or closed-loop control device 150 from the ambient temperature sensor 165c.

[0132] Similarly, two temperature sensors 165a and 165b, if both are present or required to determine temperature values ​​T1, T2 (see previous figure), are in direct or indirect signal communication with the control device or closed-loop control device 150.

[0133] In the example of FIG. 3, the control device or closed-loop control device 150 calculates the calculated temperature value T rechThis may be based on the first temperature value T1 and / or the second temperature value T2 of the first liquid, respectively, and may further be based on a temperature coefficient.

[0134] The calculated temperature value T in the blood treatment device or dialyzer 303 rech The calculation of T provides an estimate of the actual temperature of the first liquid as it flows through the blood treatment device. Knowing this estimate allows for a correlation between the estimated temperature at the blood treatment device and its setpoint T at this point. D_soll The deviation is used to determine the deviation between the setpoint T D_soll The calculated temperature value T from rech is used to prompt the heating device 162 to increase or set the dialysate temperature based on the deviation of

[0135] In this example, the ambient temperature value T Umg The effect of must be uniform.

[0136] If a linear temperature drop is assumed for each line length L1 and L2 of the line segment, the temperature coefficient T in °C / m is k can be determined for these, for example, as follows:

[0137]

number

[0138] In this regard, the following applies: T1 is the first temperature value measured by the first temperature sensor 165a downstream of the dialyzer 303 T2 is the second temperature value measured by the second temperature sensor 165b upstream of the dialyzer 303 L1: Length of the line segment, preferably on the outside, of the blood treatment device 100 upstream of the dialyzer 303 L2: Length of the line segment, preferably outside the blood treatment device 100, downstream of the dialyzer 303 If a linear relationship between temperature drop and flow rate is assumed, the following applies for a reference flow rate of 500 ml / min:

[0139]

number

[0140] Using the given equation, the control device or closed loop control device 150 calculates the temperature coefficient T k may be calculated, and through or based on this, it may be calculated how much the temperature previously reached by the heating device 162 must be adjusted to compensate for the effect of the ambient temperature. This may result in a decrease or increase in heating power.

[0141] where the calculated temperature value T of the dialyzer 303 rech In one embodiment,

[0142]

number

[0143] or

[0144]

number

[0145] and the temperature 165a at the first temperature sensor is:

[0146]

number

[0147] For example, T D_sollIf a setpoint temperature in the sense of a "desired temperature" of 37°C prevails for the dialyzer 303, a temperature value T2 of 37°C is measured by the second temperature sensor 165b upstream of the blood treatment unit, and the first temperature value T1 determined by the first temperature sensor 165a is 35°C, so that a temperature loss of 1°C is determined in each case over the lengths L1 and L2 of the line sections (here assumed to be of equal length), the calculated temperature value T for the dialyzer 303 is rech is 36°C.

[0148] T rech and T D_soll To compensate for the difference between the temperature of the dialysate and the temperature of the dialyzer 303, the heating device 162 must heat the dialysate by this difference more to reach the desired 37° C. in the dialyzer 303. The control device or closed-loop control device 150 can be programmed to control or control in a closed-loop manner the heating device 162 accordingly.

[0149] However, the example of FIG. 3 shows that the control device or closed-loop control device 150 determines the setpoint value T for the current setpoint temperature or desired temperature. 1_soll determining a first temperature value T1 of the first liquid by a first temperature sensor 165a, and comparing the first temperature value T1 with a setpoint value T 1_soll , where the first temperature value T1 is determined again and the set value T2 is increased or set by the heating device 162 based on the deviation between the first temperature value T1 and the set value T2 after a change in the heating power, such as by the heating device 162. 1_soll This procedure can be performed by a closed loop control in which the ambient temperature value T is compared with the second temperature value T2. Umg Consideration of the above can be omitted.

[0150] As can be seen from the above description, for example, internal device effects on the temperature that affect the dialysate after it has flowed past the second temperature sensor 165b are ignored here. This is harmless to a first approximation. However, in embodiments other than those described above, such internal device effects are also taken into account. This can be achieved, for example, by using the temperature coefficient T k This can be done when determining

[0151] The values, settings, coefficients, etc. disclosed herein may optionally be determined or calculated by the control device or closed-loop control device 150 within the scope of the foregoing disclosure, for example, by a corresponding computing device included in or connected to the control device or closed-loop control device 150. These values, settings, coefficients, etc. may alternatively be retrieved by the latter, respectively, from storage device 151, where they may have been initially determined by the control device or closed-loop control device 150 or computing device at a previous step or time and then stored.

[0152] Although the invention has been described herein with emphasis on blood treatment devices using dialyzers for blood treatment, the invention is not limited thereto and its use in other areas of medical technology not serving the treatment of people with kidney failure is also encompassed by the invention. [Explanation of symbols]

[0153] 100 Blood treatment device 101 Blood Pump 102 Dialysis waste outlet line 102a Connector 104 Dialysis fluid inlet line 104a connector 105 Alternate Fluid Line 107 Pre-dilution valve 107a Line associated with the pre-dilution valve 109 Post-dilution valve 109a Line associated with the post-dilution valve 111 Alternative Fluid Line 131 Ultrafiltration Pump 150 Control Device or Closed-Loop Control Device 151 Storage Devices 153 Drainage 155 Water source 157 Heat exchanger 159 First Flow Pump 161 Balancing Devices 162 Heating Devices 163 Mixed Devices 163a Conductivity Sensor 163b Conductivity Sensor 165a First temperature sensor 165b Second temperature sensor 165c Ambient Temperature Sensor 166 Concentrate supply section 167 Leak Sensor 168 Concentrate supply section 169 Second Flow Pump 171 Pump, Sodium Pump 173 Pump, bicarbonate pump 300 Extracorporeal blood circuit 301 First line (arterial line section) 302 (first) tube clamp 303 Blood filters or dialysis machines 303a Dialysis fluid chamber 303b Blood Chamber 303c semi-permeable membrane 304a Dialysis drainage port 304b Dialysis drainage port 305 Second Line (Venous Line Section) 306 (Second) Tube Clamp 315 detector 317 Single Needle Chamber 318 Degassing Device 319 Detector 325 Heparin Addition Site 329 Venous Blood Chamber (Optional) 350 Short circuit, short circuit 360 Housing Wall F1 Filter F2 Filter A container, A-concentrate, sodium B container, B-concentrate, bicarbonate K Compressed pressure source, compressor L1 Length of the first line segment L2 Length of the second line segment P Pressure measurement site PS1 Arterial Pressure Sensor (Optional) PS2 Arterial Pressure Sensor (Optional) PS3 pressure sensor (optional) PS4 pressure sensor to measure filtrate pressure (optional) PS5 pressure sensor for measuring the pressure in the dialysate inlet line T1 First temperature value T2 Second temperature value T D Temperature inside the dialysis machine T k Temperature coefficient T rech Calculated Temperature Value T D_soll Temperature setpoints in blood treatment devices T 1_soll Setpoint for temperature at first temperature sensor T Umg Ambient Temperature Value V-valve V24 valve V25 valve VB Bypass valve YY Connector

Claims

1. A control device or closed-loop control device (150) configured to control or control in a closed-loop manner the operation of a blood treatment machine (100) for treating a patient during a blood treatment session, said blood treatment machine (100) being connected to an extracorporeal blood circuit (300) and to a blood treatment device, such as a dialyzer (303) or a blood filter, wherein said blood treatment machine (100) comprises: a dialysate inlet line (104) and a dialysate outlet line (102) configured to supply dialysate to or drain dialysate from said blood treatment device (303) during said blood treatment session, respectively; a heating device (162) for heating the dialysate before or during the blood treatment session; one or several temperature sensors (165a, 165b) arranged downstream of the blood treatment device and / or downstream of the dialysate inlet line (104), at least a first temperature sensor (165a) being arranged downstream of the blood treatment device and / or downstream of the dialysate inlet line (104) in order to determine a first temperature value (T1) of a first liquid previously advanced along the dialysate inlet line (104); Furthermore, wherein the control device or closed loop control device (150) determines the first temperature value (T 1 ) a control device or closed-loop control device (150) configured to increase or set the temperature of the dialysate using the heating device (162) based on the

2. a second temperature value (T) determined or determined for the first liquid upstream of the blood treatment device and / or upstream of the dialysate effluent outlet line (102) by a second temperature sensor (165b) of the plurality of temperature sensors (165a, 165b); 2 2. The control device or closed-loop control device of claim 1, configured to increase or set the temperature using the heating device based further on:

3. The first and / or second temperature values ​​(T 1 , T 2 3. The control device or closed-loop control device (150) of claim 1 or 2, wherein the (i) is or has been determined before the start of the blood treatment session.

4. The first and / or second temperature values ​​(T 1 , T 2 4. The control device or closed-loop control device (150) of claim 1, wherein the blood pressure is determined or has been determined during the blood treatment session.

5. The first or second temperature value (T 1 , T 2 5. The control device or closed-loop control device (150) of any one of claims 1 to 4, wherein the determined value is or was determined while the dialysate inlet line (104) and the dialysate effluent outlet line (102) are or were in fluid communication with each other, excluding or bypassing the blood treatment device.

6. The first and / or second temperature values ​​(T 1 , T 2 6. The control device or closed-loop control device (150) of any one of claims 1 to 5, wherein the determined value is or was determined while the dialysate inlet line (104) and the dialysate effluent outlet line (102) are not or were not positioned to exclude or bypass the blood treatment device.

7. The first and / or second temperature values ​​(T 1 , T 2 7. The control device or closed-loop control device (150) of claim 6, wherein when or for determining (i.e., when determining (ii)), no two different liquids flow through or are present in the blood treatment device.

8. The temperature set value (T1 _soll ) the first temperature value (T 1 8. A control device or closed-loop control device (150) according to any one of claims 1 to 7, wherein a deviation of

9. The first temperature value (T 1 ) and the second temperature value (T 2 ) and the calculated temperature value (T rech ) and Setting value (T D_soll ) the calculated temperature value (T rech ) deviation, The set value T D_soll The calculated temperature value T rech 9. The control device or closed-loop control device (150) of claim 1, configured to prompt the heating device (162) to increase or set the dialysate temperature based on the deviation of the dialysate temperature from the heating device (162).

10. The calculated temperature value (T rech ) in the blood treatment device, the first and / or second temperature values ​​(T 1 , T 2 ) and temperature coefficient (T k ) of the dialysate inlet line (104), or in particular a first line segment extending outside the blood treatment device (100), in particular its length (L1), and / or the dialysate effluent outlet line (102), or in particular a second line segment extending outside the blood treatment device (100), in particular its length (L2), k 10. The control device or closed-loop control device (150) of claim 9, wherein:

11. The temperature coefficient (T k 11. The control device or closed-loop control device (150) of claim 10, configured to determine

12. One, two, or more flow rates (Q) of the first fluid through or into the blood treatment device, or through or into a short circuit of the dialysate inlet line (104) and the dialysate effluent outlet line (102) that excludes or bypasses the blood treatment device. 1 , Q 2 , Q 3 12. A control device or closed-loop control device (150) according to claim 10 or 11, configured to determine the temperature coefficient (Tk) related to the temperature of the temperature sensor.

13. During or before the blood treatment session, the first temperature value (T 1 ) and the set value (T 1_soll ) or the calculated temperature value (T rech ) and the temperature setpoint (T D_soll 13. The control device or closed-loop control device (150) of any one of claims 8 to 12, configured to increase or decrease the temperature of the dialysate by, or at least by, the difference between the temperature of the dialysate and the temperature of the dialysate using the heating device (162).

14. The first temperature value (T 1 14. The control device or closed-loop control device (150) of any one of claims 1 to 13, wherein the blood pressure is determined only downstream of the blood treatment device.

15. When the heating device (162) is used during or before the blood treatment session to raise or set the temperature to which the dialysate is brought, the temperature is adjusted to an ambient temperature value (T) determined, for example, by an ambient temperature sensor (165c) of the blood treatment machine (100). Umg 15. The control device or closed-loop control device (150) of any one of claims 1 to 14, configured to further take into account:

16. A blood treatment apparatus (100) arranged for use 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, said blood treatment apparatus comprising: at least one receptacle for releasably receiving at least one section of the extracorporeal blood circuit (300) on the blood treatment device (100); at least one receptacle for releasably receiving at least one section of said blood treatment device on said blood treatment apparatus (100); a dialysate inlet line (104) configured to supply dialysate effluent to the blood treatment device (100) during the blood treatment session, and a dialysate outlet line (102) configured to drain dialysate effluent from the blood treatment device (100), or receptacles therefor; a first temperature value (T 1 one or several temperature sensors (165a, 165b) for determining the temperature of the blood treatment device, at least the first of which (165a) is located downstream of the blood treatment device and / or downstream of the dialysate inlet line (104), a heating device (162) for heating the dialysate before or during the blood treatment session; a control device or closed-loop control device (150) according to any one of claims 1 to 15 for controlling or controlling in a closed-loop manner the operation of said blood treatment device (100); A blood treatment device (100) comprising:

17. a second temperature value (T 2 17. The blood treatment device (100) of claim 16, further comprising a second temperature sensor (165b) of the plurality of temperature sensors (165a, 165b) for determining a temperature difference (Tc).

18. Ambient temperature value (T Umg 18. The blood treatment device (100) of claim 16 or 17, further comprising or connected to an ambient temperature sensor (165c) for determining an ambient temperature (A) of the blood treatment device (100).

19. 19. The blood treatment device (100) according to any one of claims 16 to 18, embodied as a dialysis machine, a hemodialysis machine, a hemofiltration machine or a hemodiafiltration machine, in particular as a machine 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, memory card, CD or DVD, EPROM, FRAM or SSD, carrying electronically readable control signals, configured to interact with a programmable computer system so that a conventional control device or closed-loop control device is reprogrammed into a control device or closed-loop control device (150) according to any one of claims 1 to 15 and / or a conventional blood treatment apparatus is reprogrammed into a blood treatment apparatus (100) according to any one of claims 16 to 19.

21. 20. A computer program product having program code stored as signal waves or on a machine readable carrier for interacting with a programmable computer system such that a conventional control device or closed-loop control device is reprogrammed into a control device or closed-loop control device (150) according to any one of claims 1 to 15 and / or a conventional blood treatment apparatus is reprogrammed into a blood treatment apparatus (100) according to any one of claims 16 to 19.

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

Images