WO2023062047A1 - Vorrichtung zur überwachung einer blutreinigung mit einer extrakorporalen blutreinigungsvorrichtung - Google Patents
Vorrichtung zur überwachung einer blutreinigung mit einer extrakorporalen blutreinigungsvorrichtung Download PDFInfo
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- WO2023062047A1 WO2023062047A1 PCT/EP2022/078320 EP2022078320W WO2023062047A1 WO 2023062047 A1 WO2023062047 A1 WO 2023062047A1 EP 2022078320 W EP2022078320 W EP 2022078320W WO 2023062047 A1 WO2023062047 A1 WO 2023062047A1
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- blood purification
- blood
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
- A61M1/1601—Control or regulation
- A61M1/1613—Profiling or modelling of patient or predicted treatment evolution or outcome
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
- A61M1/1601—Control or regulation
- A61M1/1603—Regulation parameters
- A61M1/1605—Physical characteristics of the dialysate fluid
- A61M1/1607—Physical characteristics of the dialysate fluid before use, i.e. upstream of dialyser
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
- A61M1/1601—Control or regulation
- A61M1/1603—Regulation parameters
- A61M1/1605—Physical characteristics of the dialysate fluid
- A61M1/1609—Physical characteristics of the dialysate fluid after use, i.e. downstream of dialyser
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
- A61M1/3607—Regulation parameters
- A61M1/3609—Physical characteristics of the blood, e.g. haematocrit, urea
- A61M1/361—Physical characteristics of the blood, e.g. haematocrit, urea before treatment
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
- A61M1/3607—Regulation parameters
- A61M1/3609—Physical characteristics of the blood, e.g. haematocrit, urea
- A61M1/3612—Physical characteristics of the blood, e.g. haematocrit, urea after treatment
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/18—General characteristics of the apparatus with alarm
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- A—HUMAN NECESSITIES
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- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/33—Controlling, regulating or measuring
- A61M2205/3306—Optical measuring means
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
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- A61M2205/3317—Electromagnetic, inductive or dielectric measuring means
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- A—HUMAN NECESSITIES
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- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/50—General characteristics of the apparatus with microprocessors or computers
- A61M2205/52—General characteristics of the apparatus with microprocessors or computers with memories providing a history of measured variating parameters of apparatus or patient
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2230/00—Measuring parameters of the user
- A61M2230/20—Blood composition characteristics
- A61M2230/201—Glucose concentration
Definitions
- the invention relates to a method for monitoring blood purification with an extracorporeal blood purification device and a device for monitoring blood purification for use with an extracorporeal blood purification device, the blood purification device being designed in such a way that blood purification with predetermined treatment parameters is carried out using a blood purification unit in an extracorporeal blood circuit.
- the invention relates to an extracorporeal blood purification device with a device for monitoring blood purification and a blood purification system comprising at least two extracorporeal blood purification devices and a data processing system.
- the main tasks of extracorporeal blood purification methods include the removal of urinary substances such as urea, beta-2-microglobulin, phosphate and other uraemic toxins from the blood, as well as the supply of certain substances such as bicarbonate.
- a substance exchange takes place in a blood purification unit (dialyzer, filter, adsorber), which causes the substance concentration to change from the blood-side input to the output side as the blood flows through.
- the measure of the quality of the exchange is the substance-specific clearance K, which describes which part of the blood has been completely cleaned of the substance in question:
- Equation (1) C bi : substance concentration in the blood at the inlet of the blood chamber of the dialyzer
- C bo substance concentration in the blood at the outlet of the blood chamber of the dialyzer
- Q b blood flow
- the known blood purification devices include, for example, devices for hemodialysis, hemofiltration and hemodiafiltration.
- the blood purification unit is a dialyzer or filter separated into first and second compartments by a semipermeable membrane.
- the blood flows through the first compartment (blood chamber) of the dialyzer, which is part of an extracorporeal blood circuit, while the dialysis fluid flows through the second compartment (dialysis fluid chamber) of the dialyzer, which is part of a dialysis fluid system.
- a blood purification unit cell separator
- dialysance D can be defined instead of the clearance K if the substance of interest is also present on the dialysate side:
- Equation (2) C bi : substance concentration in the blood at the inlet of the blood chamber of the dialyzer
- C bo substance concentration in the blood at the outlet of the blood chamber of the dialyzer
- the clearance K and dialysance D are substance-dependent quantities and ideally depend only on the characteristics of the “artificial kidney” and on the specified treatment parameters that the user can set on the blood purification device. This primarily includes the extracorporeal blood flow Qb. In the case of hemodialysis, the dialysis fluid flow Qd is also relevant. In the case of convective procedures (hemo(dia)filtration), the convective flow of the substitution solution Q s is another treatment parameter.
- K and D deviate from the values expected under ideal conditions.
- the main reason is that the characteristics of blood purification are typically determined under laboratory conditions, whereby not all parameters relevant to clinical application, such as patient-specific properties of the blood and the extracorporeal blood circuit or flow conditions in the dialyzer changed by blood properties, can be taken into account. Furthermore, unnoticed deviations between the default values of the user and the actually existing flow conditions can occur on the device side in the blood purification device.
- K and D can be determined by determining the concentrations according to Equation (1) and Equation (2).
- measurements on the blood side which require direct contact of a sensor with the blood, involve the risk of contamination, so that they are generally not used for the online determination of K or D. Therefore, most methods use sensors on the dialysate side based on the assumption of conservation of mass balance across the semipermeable membrane. This assumption does not apply or only applies to a limited extent when using absorbers or membranes with absorber properties.
- a known method for the online determination of K or D is based on the dialysate-side determination of the sodium dialysance by generating a temporarily varying the sodium content upstream of the dialyzer and measuring the dialysate response of the system downstream.
- the quantification of the variation is preferably carried out by measuring a variable that correlates with the sodium concentration or the variation in the sodium concentration, in particular the conductivity of the dialysis liquid.
- the sodium dialysance determined in this way (in ml/min) is then equated with the urea clearance.
- substances e.g. potassium, creatinine, bicarbonate, etc.
- the dialysis dose Kt/V or Dt/V can be determined by integrating the continuously determined clearance K.
- a method and a device for determining the clearance K or dialysance D during an extracorporeal blood purification which is based on the online measurement of the electrolyte transfer at two different dialysate ion concentrations, is for example from DE 39 38 662 A1 (US Pat. No. 5,100,554) and DE 197 47 360 A1 (US Pat. No. 6,156,002) is known.
- Methods for determining K or D generally require an accurate measurement of the blood and dialysate-side flows at the blood purification device. Errors in the determination of these flows therefore have a direct impact on the values of K and D, respectively.
- Errors in the determination of the dialysate flow Qd can arise, for example, as a result of incomplete filling of the balancing chambers used to balance the flow on the dialysate side.
- measurements with flow sensors e.g. Coriolis flow meter
- Deviations in the blood flow actually pumped on the blood side from the target value depend on the type of pumping.
- deviations arise due to the reduction in flow due to a vacuum on the suction side and changing elastic properties of the flexed hose segment.
- An occlusion at the dialyzer inlet on the positive pressure side can also lead to an unnoticed reduction in blood flow.
- the blood flow depends heavily on the viscous properties of the medium and the flow resistance of the system, especially on the dialyzer, so that reliable delivery is not possible without precise flow sensors on the blood side.
- the relative direction of the blood flow to the dialysate flow in the dialyzer is also important for the value of K or D, since a greater mass transfer is achieved with a countercurrent connection than with a parallel flow connection. Since the blood and dialysate connections are mostly manual, unintentional mix-ups can occur.
- a recirculation which can take place both directly between the arterial and venous connection point and also systemically as so-called cardiopulmonary recirculation, means that blood that has been cleaned in the blood purification device and returned to the bloodstream venously reaches the arterial withdrawal point again without first contacting the relevant Having volume of solution mixed throughout the body. This reduces the effective cleaning performance of the blood cleaning unit. This occurs in particular when the blood flow in the patient's vascular access, the so-called shunt flow Qa, is smaller than the extracorporeal blood flow Qb. Both the pulsatile nature of the shunt flow Qa, caused by the heartbeat, and the delivery method, especially with hose reel pumps, can lead to direct recirculation, even if the mean is Qa > Qb.
- Unfavorable geometrical arrangements of the cannulas (needles) relative to one another, eg cannulas arranged too close together, can also lead to direct recirculation. In contrast to the unavoidable cardiopulmonary recirculation, the latter is an effect that needs to be detected and avoided.
- the so-called dialysis dose KtA/ which is defined as the quotient of the product of clearance K for urea and effective treatment time t of the dialysis treatment and the distribution volume V of the patient for urea, is of decisive importance for the effectiveness of dialysis treatment.
- the dialysis dose KtA/ (or Dt/V) achieved at the end of the dialysis treatment is compared with a minimum value for quality assurance purposes.
- this comparison to an absolute value does not generally allow early detection of more subtle problems in treatment that result in only small deviations from Kt/V.
- the methods and devices used to determine K and D online are influenced by various sources of error.
- the invention is based on the object of specifying a method that allows reliable monitoring of the operating state of a blood purification device, in particular specifying a method with which deviations from the normal operating state of a blood purification device can be detected at an early stage.
- the invention is based on the object of creating a device for monitoring blood purification for use with an extracorporeal blood purification device, with which blood purification can be reliably monitored.
- Another object of the invention is to provide a blood purification system that allows reliable monitoring of blood purification.
- the method according to the invention allows blood purification to be monitored using an extracorporeal blood purification device which is designed in such a way that blood purification with predetermined treatment parameters is carried out by means of a blood purification unit in an extracorporeal blood circuit.
- the blood purification device can be any device suitable for carrying out hemodialysis, hemofiltration, hemo(dia)filtration or a combination of these blood purification methods.
- Such blood purification devices belong to the prior art. With these blood purification devices, blood is taken from the patient from a vascular access via an (arterial) cannula (needle) and fed to a blood purification unit via a blood line.
- the feed pump for taking blood can be part of the blood purification device or integrated into a disposable intended for one-time use, with any method suitable for feeding the blood, in particular by means of peristaltic pumps or impeller pumps, being able to be used.
- the blood purification device means for Have dialysate processing and supply lines or discharge lines to the blood purification unit and means for fluid removal by means of ultrafiltration.
- the concentration of a substance or a variable correlating with the concentration of a substance is measured with at least one sensor during the blood purification and with a computing and/or evaluation unit, on the basis of the concentration of a substance or substance measured with the at least one sensor a variable correlating with the concentration of a substance determines at least one parameter that is characteristic of the purification performance of the blood purification unit during the blood purification carried out with the specified treatment parameters.
- a variable correlating with the concentration of a substance determines at least one parameter that is characteristic of the purification performance of the blood purification unit during the blood purification carried out with the specified treatment parameters.
- Means for changing the composition of the dialysis fluid by changing the mixing ratio of components involved in the online production of the dialysis fluid can be used to determine the quantity characteristic of blood purification, in particular the clearance K or dialysance D.
- the concentration of a substance can be both increased and decreased.
- the components of the dialysis fluid can also be provided in containers, for example bags, with a liquid or a solid being added from a separate reservoir for the measurement process, as a result of which the composition of the dialysis fluid is changed.
- the concentration of a substance or a variable correlating with the concentration of a substance can be measured during blood purification with blood-side sensors upstream and/or downstream of the blood purification unit and/or with dialysate-side sensors upstream and/or downstream of the blood purification unit, which are suitable for Concentration of a substance contained in the blood or in the dialysate or a variable correlating therewith according to any method with a contact-based or non-contact method to determine measurement.
- these can be ion-selective electrodes, conductivity sensors, spectroscopic devices for measuring in the infrared or visible range of light or in the UV range of light, sensors used in chromatographic methods (e.g.
- the connection of the sensors to the measuring points on the blood and/or dialysate side can be permanently installed in the blood purification device. However, the sensors can also only be used when the blood purification device is set up. They can also be part of a disposable on the blood and/or dialysate side. The connection of the sensors can be wired or wireless.
- a computing and/or evaluation unit is to be understood as any device that is suitable for determining a variable that is characteristic of the purification performance of the blood purification unit from the measured value or the measured values using any method.
- the method according to the invention is characterized in that the arithmetic and/or evaluation unit not only determines a variable that is characteristic of the cleaning performance, but that the arithmetic and/or evaluation unit also determines an expected value, dependent on at least one treatment parameter, for a cleaning performance of the Cleaning unit characterizing parameters determined.
- the expected value can be determined by a variety of different methods.
- the expected value can be a global value or a value that is specific to the treatment parameters of a patient set on the dialysis machine, a specific substance or substance class, a time of day or year, a dialysis center or a combination of various parameters.
- the expected value can be a value averaged over an intradialytic time interval.
- the expected value can be calculated on the basis of a mathematical model or determined by accessing tabulated values.
- the expected value can be established by comparison with other treatments. These can be treatments with the same or similar treatment parameters or with treatment parameters that differ from the present treatment, from which the expected value is then determined for the treatment parameters of the current treatment on the basis of a mathematical model. These can be current treatments from the same medical center or other centers, or historical treatments for the patient currently being treated on the device, or a combination of current and historical values.
- the variable that is characteristic of the purification performance of the blood purification unit is compared with the expected value.
- the computing and/or evaluation unit determines a tolerance range for the expected value, with actions specified by the computing and/or evaluating unit being triggered depending on whether the parameter characteristic of the cleaning performance of the blood purification unit is within or outside the tolerance range for the expected value .
- the comparison of the quantity that is characteristic of the purification performance of the blood purification unit, which can be measured during blood purification, with the expected value allows the ongoing detection of deviations in the operating state of the blood purification device and the system consisting of the blood purification device and the patient from a typical or ideal operating state.
- the user can be informed of non-tolerable deviations and/or asked to initiate suitable measures. In the event of intolerable deviations, suitable measures can also be carried out automatically.
- the computing and/or evaluation unit can carry out different actions depending on whether a deviation is tolerable or not.
- graphic elements and/or symbols can be displayed with a graphic user interface and/or acoustic signals can be generated with an acoustic user interface, with which the user is informed that the parameter characteristic of the cleaning performance of the blood purification unit is inside or outside the tolerance range for the expected value.
- the user interface can be a screen, for example, in particular a touch-sensitive screen (touch screen), on which the graphic elements and/or symbols are displayed.
- the graphical elements can, for example, be dots, dashes, lines, bars or areas that indicate the parameter characteristic of the purification performance of the blood purification unit as a function of the treatment time, the upper and/or lower limit of the tolerance range, a deviation from the tolerance range or exceeding the tolerance range.
- the symbols can have a meaning that prompts the user to take a specific action.
- An audible user interface can provide an audible alarm in the event of an intolerable deviation.
- help for finding the cause can also be offered with the user interface.
- a knowledge base (“assisted machine learning”), for example, causes identified by the user can also be entered. This can be done in free text or by selecting suggested causes.
- These user annotations, together with the relevant treatment and technical parameters, can then be sent to a server or sent to a cloud.
- control and/or evaluation unit can generate an electrical signal that signals that the parameter characteristic of the cleaning performance of the blood cleaning unit is within or outside the tolerance range for the expected value.
- This electrical signal can be further processed in the device for monitoring the blood purification device or in a device that interacts with the monitoring device, in particular the blood purification device.
- One embodiment of the method according to the invention provides that expected values for different treatment parameters are stored in a data memory, with the respective expected value for the specified treatment parameters being read out from the data memory by the computing and/or evaluation unit.
- the expected values can be stored in the data memory in the form of a table, for example.
- the expected value is calculated with the computing and/or evaluation unit, given knowledge of the properties of the blood purification unit used, according to a mathematical model that describes the expected value as a function of the specified treatment parameters.
- a predetermined treatment parameter is the blood flow.
- the properties of the cleaning unit can be determined by laboratory measurements (manufacturer information).
- a “measured value” for a parameter describing the purification performance of a blood purification unit is compared with a “calculated value”. Measurements of changes in concentration in the extracorporeal blood circuit or dialysis fluid system are not required for the calculation of the expected value according to the known models.
- a parameter characteristic of the purification performance of the blood purification unit is determined during blood purification with an extracorporeal blood purification device other than the one to be monitored and read into a data memory.
- the parameter characteristic of the purification performance of the blood purification unit can be measured using the known methods.
- the expected value determined during a previous blood purification with the other extracorporeal blood purification device is then read out from the data memory as the expected value for the blood purification with the monitoring blood purification device.
- the computing and evaluation unit can be a computing and/or evaluation unit that is spatially separate from the blood purification device and/or the data memory can be a data memory that is spatially separate from the blood purification device.
- the expected value can thus be determined on an external device in a medical center or else outside of the medical center using cloud computing.
- the transmission of raw data and/or calculated values from the device for monitoring blood purification to external computing units (cloud applications) or the transmission of expected values from external computing units to the device for monitoring blood purification can take place via a data interface.
- the device according to the invention for monitoring blood purification is designed to carry out the method according to the invention.
- the monitoring device according to the invention can form an external unit that records measured values using sensors, or it can be a component of the extracorporeal blood purification device.
- the blood purification system according to the invention comprises at least two extracorporeal blood purification devices, each designed such that blood purification is carried out with predetermined treatment parameters using a blood purification unit in an extracorporeal blood circuit, the blood purification devices each having a data interface.
- the blood purification devices each have at least one sensor for determining the concentration of a substance or a variable that correlates with the concentration of a substance during blood purification and a computing and/or evaluation unit that is configured in such a way that, on the basis of the at least one sensor measured concentration of a substance or a variable correlating with the concentration of a substance, at least one parameter characteristic of the purification performance of the blood purification unit is determined during the blood purification carried out with the predetermined treatment parameters.
- the monitoring device is part of the blood purification device.
- the blood purification system comprises a data processing system with which the at least two blood purification devices interact in such a way that data is exchanged via the data interface between the at least two blood purification devices on the one hand and/or between at least one of the blood purification devices and the data processing system on the other hand.
- the blood purification system comprises a computing and evaluation unit, which is configured in such a way that a parameter that is characteristic of the purification performance of the blood purification unit and that is determined during blood purification with one of the at least two blood purification devices is read into a data memory, and by another blood purification device of the at least two blood purification devices is read out from the data memory as the expected value.
- the computing and evaluation unit can be replaced by components of the at least two blood purification devices or components of the data processing system are formed.
- the data memory can be part of the central data processing unit and/or the blood purification devices.
- the communication between the individual devices can take place via the Internet (cloud computing).
- FIG. 1 shows the essential components of an extracorporeal blood purification device according to the invention in a simplified schematic representation
- FIG. 5 shows a blood treatment system comprising two
- Figures 9A to 9C show a trend analysis based on the total dialysis dose of the respective treatments.
- the hemodiafiltration device which is only described as an example of a blood purification device, has a dialyzer (filter) 1 which is separated into a blood chamber 3 and a dialysis liquid chamber 4 by a semipermeable membrane 2 .
- the inlet of the blood chamber 3 is connected to one end of a blood supply line 5 into which a blood pump 6 is connected, while the outlet of the blood chamber is connected to one end of a blood discharge line 7 into which a drip chamber 8 is connected.
- Blood supply and discharge lines 5, 7 together with the blood chamber 3 of the dialyzer form the extracorporeal blood circuit 9 of the hemodiafiltration device.
- the blood supply and discharge lines 5, 7 are hose lines of a hose set (disposable) inserted into the hemodiafiltration device.
- the dialysis fluid system 10 of the hemodiafiltration device includes a device 11 for providing dialysis fluid, which is connected via the first section of a dialysis fluid supply line 12 to the inlet of the first balancing chamber half 35a of a balancing device 35 .
- the second section of the dialysis fluid supply line 12 connects the outlet of the first balancing chamber half 35a to the inlet of the dialysis fluid chamber 4.
- the outlet of the dialysis fluid chamber 4 is connected via the first section of a dialysis fluid discharge line 13 to the inlet of the second balancing chamber half 35b.
- a dialysis fluid pump 14 is connected in the first section of the dialysis fluid discharge line 13 .
- the outlet of the second balance chamber half 35b is connected to an outlet 15 via the second section of the dialysis liquid discharge line 13 .
- An ultrafiltrate line 16 which also leads to the outlet 15 , branches off from the dialysis liquid discharge line 13 upstream of the dialysis liquid pump 14 .
- An ultrafiltration pump 17 is connected to the ultrafiltrate line 16 .
- the balancing device 35 consists of two parallel balancing chambers that are operated anti-cyclically.
- the patient's blood flows through the blood chamber 3 and the dialysis fluid flows through the dialysis fluid chamber 4 of the dialyzer.
- the ultrafiltration pump 17 With the ultrafiltration pump 17, a predetermined amount of liquid (ultrafiltrate) can be withdrawn from the patient at a predetermined ultrafiltration rate.
- the hemodiafiltration device has a substitution device 19, with which a substitution liquid (substituate) can be supplied to the blood, which is fed through the arterial branch 20 (pre-dilution) and/or the venous branch 21 (post-dilution) of the extracorporeal Blood circuit 9 flows.
- the substitution device 19 has a device 37 for providing substituate, from which a first substituate line 36, into which a first substituate pump 22 is connected, leads to the section of the blood supply line 5 between the blood pump 6 and the blood chamber 3.
- the hemodiafiltration device has a central control and/or computing unit 25 which, for example, has a general processor, a digital signal processor (DSP) for continuous processing of digital signals, a microprocessor, an application-specific integrated circuit (ASIC), an integrated circuit consisting of logic elements (FPGA) or other integrated circuits (IC) or hardware components may have to the individual process steps for controlling the DSP.
- DSP digital signal processor
- ASIC application-specific integrated circuit
- FPGA logic elements
- IC integrated circuits
- a data processing program (software) can run on the hardware components to carry out the method steps.
- the data processing program can be stored on a data memory of the control and/or computing unit 25 .
- the central control and/or computing unit 25 is connected to the blood pump 6, the dialysis fluid pump 14, the ultrafiltration pump 17 and the first and second substituate pumps 22, 24 via control lines 6', 14', 17', 22', 24'.
- the control and/or computing unit 25 controls the pumps in such a way that the blood purification is carried out with a predetermined blood flow rate Qb, dialysis fluid rate Qd and substitution rate Qs.
- the device according to the invention for monitoring the blood purification is described below as a component of the blood purification device.
- the monitoring device can also be a device that is spatially separate from the blood purification device.
- the monitoring device can make use of the components of the blood purification device, in particular its control and/or computing unit 25 .
- the hemodiafiltration device has a first sensor 31 arranged upstream of the dialysis fluid chamber 4 of the dialyzer 1 and a second sensor 32 arranged in the dialysis fluid discharge line 16 downstream of the dialysis fluid chamber 4, as well as a third sensor 33 arranged in the blood discharge line 7 downstream of the blood chamber 3 and a third sensor 33 arranged in fourth sensor 34 arranged in the blood supply line 20 upstream of the blood chamber 3, which is designed to measure a variable that correlates with the concentration of a substance in the dialysis fluid or the blood.
- the sensors are 31, 32, 33, 34 Conductivity sensors for measuring the conductivity of blood or dialysis fluid.
- the central computing and/or evaluation unit 25 is configured in such a way that, on the basis of the conductivity measured with at least one of the sensors 31, 32, 33, 34, a parameter that is characteristic of the cleaning performance of the dialyzer during the blood purification, which is carried out with predetermined treatment parameters , is determined.
- the conductivity is measured both on the blood side and on the dialysis liquid side. However, not all sensors need to be present to determine this parameter.
- the computing and/or evaluation unit 25 calculates during the blood purification, for example from the measured blood inlet concentration C bi and blood outlet concentration Cbo and the blood flow Qb, the clearance K according to Equation (1) or the blood inlet concentration C bi , blood outlet concentration Cbo and the dialysis fluid inlet concentration Cdi and the blood flow Qb is the dialysance D according to equation (2).
- the computing and/or evaluation unit calculates 25 Kt (t: treatment time) or Dt (t: treatment time) and the dialysis dose Kt/V (V: distribution volume) or the dialysis dose Dt/V.
- Kt treatment time
- V distribution volume
- all other known methods can also be used, for example only on the basis of measurements on the dialysate side.
- the computing and/or evaluation unit 25 is configured in such a way that an expected value K ref for the cleaning performance of the dialyzer, which is dependent on at least one treatment parameter, is determined with which the parameter determined on the basis of the conductivity measurement, which is characteristic of the cleaning performance of the dialyzer, is compared.
- the expected value K ref is calculated using a mathematical model. Such mathematical models are known.
- the expected value is calculated according to the mathematical model described in Sargent" JA, Gotch. FA: Principles and biophysics of dialysis, in: Replacement of Renal Function by Dialysis, W. Drukker, F. M. Parsons, J. F. Maher (eds). Nijhoff, The Hague 1983.
- Ddiff designates the diffusive portion of the clearance K and Q Bi the total
- the expected value K ref for the clearance K is calculated as follows, taking into account the dialysis method used:
- a value specified by the manufacturer of the dialyzer, which can be determined with laboratory measurements, can be used for the dialyzer parameter K 0 A (equation (3)) that describes the properties of the dialyzer.
- the computing and/or evaluation unit 25 can therefore also be configured such that after the determination or measurement of the clearance K, an effective value (K 0 A) eff is determined by reversing equation (3) and equation (4) during blood purification and is then used as the expected value in the same or a later treatment of the same or other patients to calculate the expected value according to equation (3) and equation (4).
- the hemodiafiltration device has a storage unit 38 which, in the present exemplary embodiment, is connected to the computing and/or evaluation unit 25 via a data line 39 .
- K 0 A or (K 0 A) eff can be read into or out of the memory unit 38 by the arithmetic and/or evaluation unit 25 .
- the computing and/or evaluation unit 25 is also configured in such a way that a tolerance range is determined for the expected value K ref .
- the tolerance range is defined by an upper and lower limit value [K min , K max ], K ref ⁇ [K min , K max ]
- the tolerance range can be symmetrical or asymmetrical around K ref .
- An assumed maximum value can be used as the upper limit for K max , e.g. the smallest value of Qbw (blood water flow) and Qd (dialysis fluid flow) in hemodiafiltration (HDF) treatments, less than or equal to Qbw in hemofiltration (HF) treatments and in absorber treatments, since the clearance cannot be greater than the flows at the dialyzer.
- the limits of the tolerance range can be defined based on the deviations of K ref in past treatments of the same or other patients.
- the computing and/or evaluation unit 25 defines an upper limit value K max that is a specific percentage, for example 10%, above the expected value K ref and a lower limit value K min that is a specific percentage, for example 10% %, is below the expected value K ref .
- the computing and/or evaluation unit 25 is also configured in such a way that it is calculated whether the measured clearance K or dialysance D is within the tolerance range, ie is smaller than K max and larger than K min . If K or D is greater than K max or less than K min , the arithmetic and/or evaluation unit 25 generates an electrical and acoustic signal which signals that an operating state is present which does not correspond to the ideal or normal operating state.
- the hemodiafiltration device has a graphic and acoustic user interface 40, which in the present exemplary embodiment includes a touch-sensitive screen 40A (touch screen) or a screen and an input device, for example a computer mouse.
- the computing and/or evaluation unit 25 is connected to the user interface 40 via a data line 41 and interacts with the user interface in such a way that graphic elements and symbols are displayed on the touch-sensitive screen 40A, which indicate to the user that the cleaning performance of the Blood purification unit characteristic parameters is within or outside the tolerance range for the expected value or prompt the user to take certain actions.
- the user interface has a loudspeaker 40B for outputting acoustic signals, for example an alarm signal.
- FIG. 2 shows screen 40A of user interface 40.
- the upper limit value K max is displayed as a horizontal top line and the lower limit value K min is displayed as a horizontal bottom line.
- the tolerance range is between the upper and lower limit Surface.
- the clearance K or dialysance D measured during blood purification is displayed as a function of the treatment time t.
- the measured clearance K or dialysance D can be displayed continuously on the screen or only after the end of the treatment. The user can immediately see on the screen whether the measured clearance K or dialysance D deviates from the expected value by a tolerable value.
- the clearance K is within the tolerance range.
- symbols 42, 43 are displayed on the screen 40A.
- a symbol 42 appears on the screen, for example, which prompts the user to take a specific action, for example entering specific data.
- Buttons 44, 45, 46 buttons are also shown on the screen, which the user can press when certain actions are to be carried out. These actions can also be carried out automatically as soon as the arithmetic and/or evaluation unit 25 has determined that the operating state is not normal.
- FIG. 3 shows the screen 40A, with the clearance K falling below the lower limit value K min during the treatment and thus lying outside the tolerance range. If the clearance K falls below the lower limit value Kmin , an acoustic alarm signal is generated with the loudspeaker 40B.
- the expected value K ref is not calculated.
- Expected values K ref for different treatment parameters are stored in the data memory 38 in the form of a table.
- different blood flows Qb are each assigned an expected value.
- Corresponding tables for different dialyzer types can be stored in the data memory 38 .
- the computing and/or evaluation unit 25 is configured in such a way that the respective expected value K ref for the specified treatment parameter, for example the blood flow Qb, or the predetermined treatment parameters, for example blood flow Qb and dialysis fluid flow Qd, are read out from the data memory 38 and used as a basis for further calculation.
- the computing and/or evaluation unit 25 can also be configured in such a way that a parameter determined during a previous blood purification with the extracorporeal blood purification device on the basis of a conductivity measurement, which parameter is characteristic of the purification performance of the dialyzer, is read into the data memory 38 and this Parameter as the expected value K ref read the blood purification of a subsequent blood purification from the data memory 38 and the further calculation is based.
- Fig. 4 shows an embodiment that differs from the embodiment described with reference to Fig. 3 in that the data memory 38' is not part of the blood purification device or the device for monitoring the blood purification, but is spatially separated from the blood purification device or the monitoring device is.
- the blood purification device or monitoring device therefore has a data interface 47 for exchanging data with the data memory 38'.
- the data transmission can take place, for example, via the Internet (cloud computing), so that a plurality of blood purification devices can exchange data with one another in order to create a database that can be accessed in order to read out the appropriate expected value or to read out data for determining the expected value .
- FIG. 5 shows a blood purification system comprising two extracorporeal blood purification devices A and B, for example hemodiafiltration devices described with reference to FIG. 4, and a data processing system C.
- the blood purification system can also include more than two hemodiafiltration devices.
- the majority of hemodiafiltration devices A, B work with the Data processing system C together in such a way that data is exchanged via its data interface 47 between the plurality of hemodiafiltration devices on the one hand and/or between a hemodiafiltration device and the data processing system on the other hand.
- the control and/or computing units 25 of the hemodiafiltration devices A, B and/or the data processing system C are configured in such a way that, for example, the clearance K or dialysance D as a parameter that is characteristic of the cleaning performance of the dialyzer that occurs during blood purification with one of the hemodiafiltration devices is determined on the basis of a conductivity measurement, is read into a data memory, and is read out from the data memory by a different hemodiafiltration device as the expected value.
- the data memory can be a data memory 38 of the hemodiafiltration device A, B and/or a data memory 38′′ of the data processing system C.
- the data transmission can take place, for example, via the Internet (cloud computing).
- the parameter characteristic of the purification performance of the blood purification unit which is determined on the basis of a conductivity measurement, can also be (K 0 A)eff.
- (K 0 A)eff can be calculated according to Equations (3) and (4) and read into the data memory and (K 0 A)eff can be read out from the data memory as the expected value for the blood purification of a subsequent blood purification and used as a basis for the further calculation.
- Equation (5) fref can be determined on the basis of theoretical considerations or information provided by the manufacturer of the blood purification unit, or on the basis of measurements in the current treatment of the patient or measurements in previous treatments of the same or other patients. It is advantageous here to use only the blood water flow QbW as a reference instead of the entire whole blood flow Qb.
- the parameters Q b , Q d , Q s , K, V b and Kt were registered and evaluated over a period of approx. 6 months.
- a sliding mean value was continuously formed for these parameters or for derived parameters and a tolerance range was determined from the variation (standard deviation ⁇ ), with a width of ⁇ 4 ⁇ around the mean value being used in the example shown. After falling below the tolerance range, the previously valid tolerance range was no longer updated.
- Figures 6A, 6B and 6C show the result of the analysis based on individual clearance measurements which were carried out multiple times per treatment. For the comparison of the measured parameter characteristic of cleaning performance, the following references were used.
- S/N signal-to-noise ratio
- FIGS. 7A, 7B, 7C show trend analyzes for K ref /Qb (FIG. 7A), K ref /K ref model (FIG. 7B), KOA/KOAstd (FIG. 7C) based on only one clearance measurement at the middle of the treatment .
- FIG. 8 shows an analysis in which the blood water flow Qbw was used for normalization instead of the whole blood flow Qb. The S/N remains unchanged.
- Figures 9A, 9B and 9C show trend analyzes for K ref *t/Vb (time integral instead of current value) (Fig. 9A), K ref *t/ K ref model*t (Fig. 9B), KOA/KOAstd (Fig 9C) based on the total dialysis dose achieved in the respective treatments, which results from the integration of the individual clearance values of a treatment.
- K 0 A mean values were formed from the individual clearance values and the flows. All analyzes show an improved S/N compared to the analysis based on individual clearance values, whereby the best selectivity could again be achieved on the basis of a comparison of the measured clearance with the clearance model as a reference.
- a deviation from the normal or ideal operating condition can be identified on the basis of a comparison of the measured clearance with an expected value of the clearance, which can be calculated using the given blood purification parameters.
- the course of the concentration of a specific substance or substance class can be measured during a dialysis treatment with suitable sensors downstream of the dialyzer. Such sensors can be based on the measurement of absorption in the infrared or visible range of light or in the UV range of light. Alternatively, the fluorescent light can also be determined when excited with a preferred wavelength (approx. 250-450 nm). Raman spectroscopy can also be used. Alternatively, substance-specific chemosensors are also possible. The fractional substance-specific dialysis dose KtA/ can then be calculated from a signal that is proportional to the course of the concentration. If the substance-specific volume of distribution is known, the substance-specific clearance K can also be calculated. This substance-specific clearance can then also be compared with corresponding reference values using the methods described.
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Abstract
Description
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CN202280069056.5A CN118103084A (zh) | 2021-10-14 | 2022-10-11 | 用于监控借助体外血液净化设备的血液净化的设备 |
AU2022366151A AU2022366151A1 (en) | 2021-10-14 | 2022-10-11 | Device for monitoring blood purification using an extracorporeal blood purification device |
EP22802561.5A EP4415775A1 (de) | 2021-10-14 | 2022-10-11 | Vorrichtung zur überwachung einer blutreinigung mit einer extrakorporalen blutreinigungsvorrichtung |
CA3235225A CA3235225A1 (en) | 2021-10-14 | 2022-10-11 | Method and device for monitoring blood purification with an extracorporeal blood purification device |
KR1020247012247A KR20240088841A (ko) | 2021-10-14 | 2022-10-11 | 체외 혈액 정화 디바이스를 사용하여 혈액 정화를 모니터링하기 위한 디바이스 |
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DE102021126681.5 | 2021-10-14 | ||
DE102021126681.5A DE102021126681A1 (de) | 2021-10-14 | 2021-10-14 | Verfahren und Vorrichtung zur Überwachung einer Blutreinigung mit einer extrakorporalen Blutreinigungsvorrichtung |
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EP (1) | EP4415775A1 (de) |
KR (1) | KR20240088841A (de) |
CN (1) | CN118103084A (de) |
AU (1) | AU2022366151A1 (de) |
CA (1) | CA3235225A1 (de) |
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Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
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DE3938662A1 (de) | 1989-11-21 | 1991-07-18 | Fresenius Ag | Verfahren zur in-vivo-bestimmung von parametern der haemodialyse |
WO1995032010A1 (en) * | 1994-05-24 | 1995-11-30 | Baxter International Inc. | Method and system for optimizing dialysis clearance |
DE19747360A1 (de) | 1997-10-27 | 1999-04-29 | Polaschegg Hans Dietrich | Verfahren zur Messung von Leistungsparametern von Stoff- und Energieaustausch Modulen |
EP1396274A1 (de) * | 2002-09-05 | 2004-03-10 | Gambro Lundia AB | Steuerung und Steuerverfahren für eine Blutbehandlungsvorrichtung |
US20140291244A1 (en) * | 2013-03-28 | 2014-10-02 | B. Braun Avitum Ag | Method and device for determining a recirculation state |
-
2021
- 2021-10-14 DE DE102021126681.5A patent/DE102021126681A1/de active Pending
-
2022
- 2022-10-11 EP EP22802561.5A patent/EP4415775A1/de active Pending
- 2022-10-11 CA CA3235225A patent/CA3235225A1/en active Pending
- 2022-10-11 KR KR1020247012247A patent/KR20240088841A/ko unknown
- 2022-10-11 CN CN202280069056.5A patent/CN118103084A/zh active Pending
- 2022-10-11 WO PCT/EP2022/078320 patent/WO2023062047A1/de active Application Filing
- 2022-10-11 AU AU2022366151A patent/AU2022366151A1/en active Pending
Patent Citations (7)
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DE3938662A1 (de) | 1989-11-21 | 1991-07-18 | Fresenius Ag | Verfahren zur in-vivo-bestimmung von parametern der haemodialyse |
US5100554A (en) | 1989-11-21 | 1992-03-31 | Fresenius Ag | Method for the in-vivo determination of hemodialysis parameters |
WO1995032010A1 (en) * | 1994-05-24 | 1995-11-30 | Baxter International Inc. | Method and system for optimizing dialysis clearance |
DE19747360A1 (de) | 1997-10-27 | 1999-04-29 | Polaschegg Hans Dietrich | Verfahren zur Messung von Leistungsparametern von Stoff- und Energieaustausch Modulen |
US6156002A (en) | 1997-10-27 | 2000-12-05 | Fresenius Medical Care Deutschland Gmbh | Method of measuring the efficiency of mass and energy transfer in hemodialysis |
EP1396274A1 (de) * | 2002-09-05 | 2004-03-10 | Gambro Lundia AB | Steuerung und Steuerverfahren für eine Blutbehandlungsvorrichtung |
US20140291244A1 (en) * | 2013-03-28 | 2014-10-02 | B. Braun Avitum Ag | Method and device for determining a recirculation state |
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CA3235225A1 (en) | 2023-04-20 |
DE102021126681A1 (de) | 2023-05-25 |
EP4415775A1 (de) | 2024-08-21 |
AU2022366151A1 (en) | 2024-04-11 |
CN118103084A (zh) | 2024-05-28 |
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