EP4648816A1 - Steuer- oder regelvorrichtung fuer eine blutbehandlungsvorrichtung zur regelung der clearance bei der dialyse - Google Patents
Steuer- oder regelvorrichtung fuer eine blutbehandlungsvorrichtung zur regelung der clearance bei der dialyseInfo
- Publication number
- EP4648816A1 EP4648816A1 EP24700868.3A EP24700868A EP4648816A1 EP 4648816 A1 EP4648816 A1 EP 4648816A1 EP 24700868 A EP24700868 A EP 24700868A EP 4648816 A1 EP4648816 A1 EP 4648816A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- blood
- dialysate flow
- dialysis fluid
- control
- blood treatment
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Classifications
-
- 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
- A61M1/1615—Control or regulation using measurements made at different flow rates
-
- 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
-
- 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
- A61M2205/33—Controlling, regulating or measuring
- A61M2205/3317—Electromagnetic, inductive or dielectric measuring means
-
- 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
- A61M2205/33—Controlling, regulating or measuring
- A61M2205/3331—Pressure; Flow
- A61M2205/3334—Measuring or controlling the flow rate
-
- 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
- A61M2230/65—Impedance, e.g. conductivity, capacity
Definitions
- Control or regulating device for a blood treatment device for regulating clearance during dialysis The present invention relates to a control or regulating device for controlling or regulating a blood treatment device according to claim 1 and a blood treatment device according to claim 9, furthermore to a digital storage medium according to claim 11, a computer program product according to claim 12 and a computer program according to claim 13 or according to the respective preambles or generic terms of these claims.
- the efficiency of blood purification by means of the blood filter or dialyzer can be indicated by the degree of clearance.
- the clearance is determined primarily by the properties of the membrane of the blood filter, by parameters of the blood filter, as well as the blood flow in the blood chamber and the dialysate flow in the dialysis fluid chamber of the blood filter.
- the blood purification that benefits the patient is reduced on the patient side by recirculation, which describes the proportion of blood that has already been purified in the blood filter and that returns to the arterial line after being returned via a venous line into the patient's vascular system without equilibration with the total body reservoir having taken place.
- Reasons for this can be cardiopulmonary recirculation or direct Fresenius Medical Care GmbH Recirculation in the vascular access or central venous catheter. When a "patient" is mentioned here, this means a person whose blood requires treatment.
- hemodialysis the exchange of substances or removal of uremic toxins occurs primarily by diffusion. This is determined by the concentration gradient between the blood and the dialysis fluid and the clearance. This mechanism is particularly effective for small molecules such as urea. Since the diffusion rate decreases with increasing molecular size, diffusion is less effective for larger molecules. Here, convective removal via ultrafiltration is more effective. This process is used in hemofiltration (HF). Hemodialysis and hemofiltration can be combined to form hemodiafiltration (HDF). By selecting the operating parameters in the HDF, the substance-specific proportion of diffusion and convection can be set within certain limits.
- K is the urea clearance in the blood filter in the unit [ml/min]
- t is the treatment time in minutes [min]
- V is the urea distribution volume or the patient's body water in the unit [ml].
- All statements made here about urea also apply to other uremic toxins according to the invention.
- Fresenius Medical Care Anlagen GmbH it is advantageous to select the dialysis parameters so that the highest possible dialysis dose is achieved.
- the exchange of substances in the blood filter can also cause undesirable side effects. This includes, in particular, dialysis disequilibrium syndrome.
- One object of the present invention may be to provide a further control or regulating device for controlling or regulating Fresenius Medical Care GmbH of a blood treatment device and a further blood treatment device.
- the object according to the invention is achieved by a control or regulating device for controlling or regulating a blood treatment device with the features of claim 1 and a blood treatment device with the features of claim 9.
- it is achieved by means of a digital storage medium with the features of claim 11, a computer program product with the features of claim 12 and a computer program with the features of claim 13.
- the control or regulating device is configured to control or regulating an extracorporeal blood treatment device when it is connected to it in a signal connection.
- the blood treatment device is used for the extracorporeal treatment of the blood of a patient in a blood treatment session and for this purpose has a blood filter (herein also: dialyzer), or is connected to it, which is divided into a blood chamber and a dialysis fluid chamber by means of a semipermeable membrane.
- a blood filter herein also: dialyzer
- dialyzer dialyzer
- Dialysate flow can mean the fluid flow flowing into and/or out of the dialysis fluid chamber.
- Fresenius Medical Care GmbH The control or regulating device according to the invention is further configured to determine or set a dialysate flow for an extracorporeal blood treatment, generated by or by means of the extracorporeal blood treatment device. It is configured such that the dialysate flow flowing through the dialyzer of the blood treatment device is determined or set such that a first dialysate flow and a second dialysate flow alternate over a large number of consecutive time intervals (e.g. identical or different, variable or constant time intervals) within the blood treatment session under consideration.
- the first dialysate flow is higher than the second dialysate flow, or alternatively lower.
- the control or regulating device can be programmed as above.
- a computing and/or evaluation unit is configured as described, i.e. in particular for determining or setting the dialysate flow.
- the computing and/or evaluation unit can be part of the control or regulating device, or can be separate from it. In the latter case, the control or regulating device can be in signal connection with the computing and/or evaluation unit or be prepared for this.
- the blood treatment device according to the invention has a control or regulating device according to the invention, is connected to it in signal connection or is configured for this purpose.
- a digital, in particular non-volatile, storage medium according to the invention in particular in the form of a Fresenius Medical Care GmbH machine-readable carrier, in particular in the form of a diskette, memory card, CD, DVD, EPROM, FRAM (Ferroelectric RAM) or SSD (Solid-State Drive), in particular with electronically or optically readable control signals, can interact with a programmable computer system in such a way that a conventional control or regulating device of a blood treatment device is reprogrammed into a control or regulating device according to the invention.
- a programmable computer system in such a way that a conventional control or regulating device of a blood treatment device is reprogrammed into a control or regulating device according to the invention.
- a computer program product has a volatile, fleeting program code or a signal wave stored on a machine-readable carrier, by means of which a conventional control or regulating device of a blood treatment device is reprogrammed into a control or regulating device according to the invention when the computer program product runs on a computer.
- a computer program product can be understood as, for example, a computer program stored on a carrier, an embedded system as a comprehensive system with a computer program (e.g. electronic device with a computer program), a network of computer-implemented computer programs (e.g. client/server system, cloud computing system, etc.) or a computer on which a computer program is loaded, runs, is stored, executed or is developed.
- machine-readable carrier refers in certain embodiments of the present invention to a carrier that contains data or information that can be interpreted by software and/or hardware.
- the carrier can be a data carrier, such as a diskette, Fresenius Medical Care GmbH can be a CD, DVD, USB stick, flash card, SD card and the like, as well as any other memory or storage medium mentioned herein.
- a computer program according to the invention comprises a program code by means of which a conventional control or regulating device of a blood treatment device is reprogrammed into a control or regulating device according to the invention when the computer program is run on a computer.
- Embodiments according to the invention can have some, some or all of the following features in any combination, provided that this is not recognizably technically impossible for the person skilled in the art.
- the use of the expression “can be” or “can have” etc. is to be understood as synonymous with “is preferably” or “preferably has” etc. and is intended to explain embodiments according to the invention.
- numerical words are mentioned herein, the person skilled in the art understands this as an indication of a numerical lower limit. If this does not lead to a contradiction that is recognizable to the person skilled in the art, the person skilled in the art will therefore always read “at least one” or “at least one” when specifying “a” or “an”.
- this represents an exemplary embodiment according to the invention, which is not to be understood as limiting.
- the object according to the invention has one or more features in a certain embodiment, it is also disclosed here that the object according to the invention expressly does not have this or these features in other embodiments that are also according to the invention, e.g. in the sense of a disclaimer.
- the opposite embodiment for example formulated as a negation, is also disclosed.
- the control or regulating device according to the invention is configured in some embodiments to carry out one, several or all of these method steps, in particular if this is done automatically.
- Fresenius Medical Care GmbH are to be carried out in any combination or to control corresponding devices, which are preferably based on the name of the respective method step (e.g. "determining” as a method step and “device for determining” for the device, etc.) and which can also be part of the device(s) according to the invention or can be connected to it in a signal connection.
- determining as a method step and “device for determining” for the device, etc.
- these terms can be interchangeable in some embodiments.
- a signal or communication connection between two components this can be understood to mean a connection that is in use. This can also be understood to mean that there is preparation for such a signal connection (wired, wireless or implemented in another way), for example by coupling both components, for example by means of pairing, etc.
- Pairing is a process that takes place in connection with computer networks in order to establish an initial link between computer units for the purpose of communication.
- the best known example of this is the establishment of a Bluetooth connection, by means of which different devices (e.g. smartphone, headphones) are connected to one another. Pairing is sometimes also referred to as bonding.
- the control or regulating device can perform all or substantially all of the functions mentioned here. Fresenius Medical Care GmbH initiates method steps. The method disclosed herein can be carried out essentially or completely by the control or regulating device. It can be carried out partially by the control device, in particular those steps which do not require or involve human intervention and/or provision can be carried out by the control device.
- the control device can serve as a pure control device or also as a regulating device.
- control or regulating device is present in or on the blood treatment device, for example together with other components or devices of the blood treatment device in a common housing of the blood treatment device.
- control or regulating device has a measuring device for measuring at least one variable characteristic of the clearance, or is connected to it in a signal connection or is prepared for this purpose.
- the control or regulating device is configured in these embodiments to determine the level or value of the first dialysate flow and/or the second dialysate flow on the basis of the at least one characteristic variable for the clearance. Alternatively, it is configured to determine a target value for the first dialysate flow and/or the second dialysate flow on the basis of the at least one characteristic value.
- control or regulating device has an estimation device for estimating the clearance instead of the measuring device.
- This Fresenius Medical Care GmbH can, for example, be carried out in a simple manner if the dialyzer parameter K 0 A and the set or measured flows are known. This case is of economic importance in particular for "low-cost devices" or acute devices without clearance measurement.
- a communication device is provided via which the user can make inputs to determine the clearance.
- Such inputs can be or include, for example, a previously defined mean clearance or target clearance K_target intended to be achieved by means of the treatment session (related to the entire treatment session or individual time intervals), the parameter of the blood filter, its effective value, the patient's shunt flow, his cardiac output, the recirculation known from previous treatments, and results of clearance determinations from previous treatments of the patient currently being treated or other patients.
- the control or regulating device is configured to determine or set a first time portion for each time interval considered from the plurality of time intervals, during which time portion dialysis fluid is conveyed through the dialysis fluid chamber with the first dialysate flow within the time interval considered.
- the first dialysate flow can be the same, i.e. constant, in every time interval. Alternatively, it can be different in some or all of the time intervals of the blood treatment session.
- the second dialysate flow can be the same, i.e. constant, in every time interval. Alternatively, it can be different in some or all of the time intervals of the blood treatment session.
- the control or regulating device sets or determines a pattern in which the dialyzer is alternately flowed through by the first dialysate flow and the second dialysate flow. In some embodiments, the control or regulating device sets or determines the times for, e.g. periodically successive, switching processes between the first dialysate flow and the second dialysate flow.
- the first dialysate flow can be a maximum dialysate flow that can be set on the blood treatment device. Alternatively or additionally, the second dialysate flow through the dialysis fluid chamber can be zero.
- Such a dialysate flow through the dialysis fluid chamber equal to zero can be achieved, for example, by switching off the dialysis fluid production or its conveyance, or by directing the dialysis fluid past the dialysis fluid chamber, for example by means of a bypass line.
- the first time portion during which dialysis fluid is conveyed through the dialysis fluid chamber with the first dialysate flow within the time interval under consideration, and the second time portion during which dialysis fluid is conveyed through the dialysis fluid chamber of the blood filter with the second dialysate flow within the time interval under consideration can be determined such that the blood conveyed through the blood chamber during the time interval under consideration is cleaned with a predetermined average clearance as it passes through the blood chamber of the blood filter within the time interval under consideration.
- control or regulating device is configured to be in signal communication with one or more sensors of a measuring device during use and/or to determine the clearance from the signals transmitted to it by the sensors or in another way.
- control or regulating device is configured to determine the first time portion during which dialysis fluid is conveyed through the dialysis fluid chamber with the first dialysate flow within the time interval under consideration and/or the second time portion during which dialysis fluid is conveyed through the dialysis fluid chamber with the second dialysate flow within the time interval under consideration based on the values determined, in particular measured, by the sensors in such a way that Fresenius Medical Care GmbH so that the previously defined average clearance is achieved within the time interval under consideration.
- control or regulating device has a communication device or is in signal connection with it or is prepared for this purpose, by means of which one or more values can be entered, for example values for time portions, time durations or intervals, the level of the average clearance, the clearances in the first time portion or in the second time portion or the like. These values are particularly suitable or provided for determining or setting the dialysate flows which are required for the extracorporeal blood treatment.
- the blood treatment device according to the invention has a dialyzer or is connected to one.
- the dialyzer is in turn divided by means of a semipermeable membrane into a blood chamber and a dialysis fluid chamber, whereby the blood chamber can be flowed through by blood with a predetermined blood flow and the dialysis fluid chamber can be flowed through by dialysis fluid with a predetermined dialysate flow.
- the blood treatment device is designed as a dialysis device, hemodialysis device, hemofiltration device or hemodiafiltration device, in particular as a device for acute, chronic renal replacement therapy or for continuous renal replacement therapy (CKRT). Fresenius Medical Care GmbH
- a change in clearance is not caused by a change in blood flow.
- the control or regulating device is not configured to specifically influence the clearance by changing the blood flow.
- blood flow plays no role in calculating flows by means of the control or regulating device to achieve the desired or previously defined average clearance, in particular not for the respective time interval.
- the control and regulating device is not configured to determine a difference between a clearance based on values measured with the sensors and the previously defined average clearance, in particular for the respective time interval. In particular, it is not configured to cause an increase or decrease in the dialysate flow based on the calculation of the difference.
- a plurality of consecutive time intervals is understood to mean at least 2, at least 5, at most 6, at most 10, at most 15, at most 100, at most 500 and/or combinations thereof, e.g. at least 2 but at most 5.
- the total duration of the (added up) time intervals is not longer than the duration of the treatment session.
- the length of the time interval from the plurality of time intervals is known before the start of the time interval under consideration or before Fresenius Medical Care GmbH The start of the time interval under consideration is determined by the control or regulating device.
- the length of the first time portion and/or the second time portion of the time interval under consideration is known before the start of the time interval under consideration or is determined by the control or regulating device before the start of the time interval under consideration.
- the length of the time interval can be stored in a memory device.
- a time interval has a predetermined duration. This can be known in advance. If the time interval is extended during treatment, or if a further time interval is appended to the time interval in such a way that the same dialysate flow is used for treatment across the boundary between the time interval under consideration and the appended further time interval, this does not contradict the other disclosures made herein.
- control or regulating device is not configured to make the length of the first and/or second time portion of the time interval dependent on the result of the clearance measurement.
- this term may be replaced by “fixing” or “setting” in some embodiments.
- the present invention is to be used to influence clearance K, changes in blood flow can be advantageously eliminated by means of mostly manual adjustments by the user or complex adjustments to the monitoring system of the blood treatment device by the manufacturer, which are impractical.
- Another possibility for reducing clearance K is the arrangement in the cocurrent principle, i.e. blood and dialysis fluid flow through the blood filter in the same direction, whereby a reduction of around 20% can be achieved.
- a change to the more efficient countercurrent principle in which blood and dialysis fluid flow through the blood filter in opposite directions, is then practically impossible.
- Another advantage of the present invention may be that a reduction in clearance K can also be achieved with the more efficient countercurrent principle.
- a further advantage of the present invention can be to advantageously avoid hemofiltration (without diffusive exchange), in which (typically in the devices equipped for hemofiltration) low convective flows and thus low clearances K can be set.
- the process of hemofiltration without diffusive exchange is due to the increased technical Fresenius Medical Care GmbH effort and the associated costs.
- the present invention the increased technical effort can be avoided and the associated much higher costs can be saved.
- the availability of the present invention is significantly increased compared to the hemofiltration process (without diffusive exchange). Blood treatment devices with fixed flow rates are less complex and less expensive.
- dialysate flow in the blood treatment devices of the prior art cannot be regulated at will either, but is often set to only a few fixed flow rates, e.g. 300 and 500 ml/min, or certain minimum flow rates.
- this problem of the lack of controllability on the dialysate side when reducing the clearance K can also be advantageously avoided.
- a further advantage of the present invention can be that it makes it possible to add medication in the arterial branch of the system, instead of in the venous branch as is common practice.
- FIG. 1 shows a simplified schematic of a fluid line structure of a blood treatment device according to the invention in a first embodiment
- Fig. 2 shows a blood treatment device according to the invention with a control or regulating device according to the invention in use in a first embodiment
- Fig. 3 shows the time sequence of a clearance-controlled change in the dialysate flow during the treatment of a patient by means of a blood treatment device according to the invention, having a control or regulating device according to the invention, in a further embodiment
- Fig. 4 shows a kinetic 2-pool model for the exchange of substances between body compartments IC and EC. Fresenius Medical Care Deutschland GmbH
- Fig. 5a shows a simulation of the material concentration curve assuming an intercompartment clearance of 800 ml/min
- Fig. 5a shows a simulation of the material concentration curve assuming an intercompartment clearance of 800 ml/min
- Fig. 5a shows a simulation of the material concentration curve assuming an intercompartment clearance of 800 ml
- FIG. 5b shows a simulation of the material concentration curve assuming an intercompartment clearance of 100 ml/min
- Fig. 6a shows a possible concentration curve on the dialysate side downstream of the blood filter without fluid removal by ultrafiltration
- Fig. 6b shows a possible concentration curve on the dialysate side downstream of the blood filter with fluid removal by ultrafiltration.
- Fig. 1 shows a fluid line structure of a blood treatment device 100 according to the invention in a first embodiment. The blood treatment device is shown in Fig. 1 only by individual, schematically partly greatly simplified components.
- the blood treatment device 100 which is shown in an at least partially upgraded state of use, is connected to an extracorporeal blood circuit 300, which can be connected to the vascular system of the patient (not shown) for treatment by means of double-needle access, or using, for example, an additional Y-connector (reference symbol Y) as shown in Fig. 1, by means of single-needle access and optionally does not belong to the blood treatment device 100, but in other embodiments does.
- the blood circuit 300 can Fresenius Medical Care GmbH can optionally be present in sections thereof in or on a blood cassette.
- the blood circuit 300 has an arterial patient tube clamp 302 and an arterial connection needle (not shown in Fig. 1) of an arterial section or an arterial patient line, blood collection line or first line 301 (or is connected thereto).
- the blood circuit 300 also has a venous patient tube clamp 306 and a venous connection needle (not shown in Fig. 1) of a venous section, a venous patient line, blood return line or second line 305 (or is connected thereto).
- a blood pump 101 is provided in or on the first line 301, an optional substituate pump 111 is connected, for example, to a dialysis fluid supply line 104 for conveying fresh dialysis fluid, which is filtered in a filter stage (filter F2) (substituate).
- An optional substituate line 105 can be fluidically connected, for example, to a dialysis fluid supply line 104.
- substituate can be supplied by predilution, via an optional predilution valve 107, or Fresenius Medical Care GmbH can be introduced into line sections, for example into the arterial line section 301 or into the venous line section 305 (here between a blood chamber 303b of a blood filter 303 and a venous air separation chamber or a venous bubble trap 329) of the blood circuit 300 by post-dilution, via an optional post-dilution valve 109, via optional, associated lines 107a or 109a.
- the blood filter 303 has the blood chamber 303b connected to the arterial line section 301 and to the venous line section 305.
- a dialysis fluid chamber 303a of the blood filter 303 is connected to the dialysis fluid inlet line 104 leading to the dialysis fluid chamber 303a and to a dialysate outlet line 102 leading away from the dialysis fluid chamber 303a, which conducts dialysate, i.e. used dialysis fluid.
- Suitable connectors are used for this purpose on the dialysis fluid inlet line 104 or on the dialysate outlet line 102 on the one hand and on the dialysate ports of the blood filter 303 on the other hand, which can be connected to one another, in particular detachably.
- the dialysis fluid chamber 303a and the blood chamber 303b are separated from one another by a mostly semi-permeable membrane 303c.
- the arrangement of Fig. 1 comprises an optional detector 315 for detecting air and/or blood.
- the arrangement of Fig. 1 optionally further comprises one or two pressure sensors PS1 (upstream of the blood pump 101) and PS2 (downstream of the blood pump 101, it measures the pressure upstream of the blood filter 303 (“pre-hemofilter”)) at the locations shown in Fig. 1. Additional pressure sensors can be provided, e.g. the pressure sensor PS3 downstream of the venous bubble catcher 329.
- An optional single-needle chamber 317 is used in Fig. 1 as a buffer and/or compensation container in a single-needle method in which the patient is connected to the extracorporeal blood circuit 300 by means of only one of the two blood lines 301, 305.
- An addition point 325 for heparin or another, in particular local, anticoagulant can be provided optionally.
- an optional mixing device 163 is shown, which provides a predetermined mixture for the respective solution for use by the blood treatment device 100 from the containers A (for A concentrate via the concentrate supply 166) and B (for B concentrate via the concentrate supply 168).
- the solution contains water from the water source 155 (online, e.g.
- An optional pump 171 which can be referred to as a concentrate pump or sodium pump, is connected to the mixing device 163 and a source of sodium, such as the Fresenius Medical Care GmbH container A, fluidically connected and/or conveys from it.
- An optional pump 173, which is assigned to container B, for example for bicarbonate, can be seen.
- an outflow 153 for the effluent can be seen in Fig. 1.
- An optional heat exchanger 157 and an optional first flow pump 159 which is suitable for degassing, complement the arrangement shown.
- the ultrafiltration pump 131 represents a means for precisely removing a volume of liquid specified by the user and/or by the control or regulating device 150 from the balanced circuit. Blood that leaves the blood filter 303 flows through an optional venous bubble trap 329, which can have a venting device 318 and can be in fluid communication with the pressure sensor PS3.
- the exemplary arrangement shown in Fig. 1 has the control or regulating device 150 according to the invention.
- the latter can be in wired or wireless signal connection with each of the components mentioned here - in any case or in particular with the blood pump 101 - for controlling or regulating the blood treatment device 100.
- Fresenius Medical Care GmbH By means of the device for online mixing of the dialysis fluid, a variation of its sodium content, controlled by the control or regulating device 150, is possible within certain limits.
- the measured values determined by means of conductivity sensors 163a, 163b can be included. Should an adjustment of the sodium content of the dialysis fluid (sodium concentration) or of the substituate prove necessary or desired, this can be done by adjusting the delivery rate of the sodium pump 171.
- the blood treatment device 100 comprises means for conveying fresh dialysis fluid and dialysate.
- An optional first valve V24 can be provided between the first flow pump 159 and the blood filter 303, which opens or closes the inlet to the blood filter 303 on the inlet side.
- a second, optional flow pump 169 is e.g. B. downstream of the blood filter 303, which conveys dialysate to the outflow 153.
- a second valve V25 can be provided between the blood filter 303 and the second flow pump 169, which opens or closes the outlet on the output side.
- the blood treatment device 100 optionally comprises a device 161 for balancing the flow flowing into and out of the dialyzer 303 on the machine side.
- the balancing device 161 is preferably arranged in a line area between the first flow pump 159 and the second flow pump 169.
- Sensors such as the optional conductivity sensors 163a, 163b serve to determine the, in some embodiments Fresenius Medical Care GmbH temperature-compensated conductivity and the liquid flow upstream and downstream of the dialyzer 303.
- Optional temperature sensors 165a, 165b can be provided individually or in groups. Temperature values supplied by them can be used according to the invention to determine a temperature-compensated conductivity.
- a leakage sensor 167 is optionally provided. Alternatively, it can also be provided at another location. Additional flow pumps, in addition to or alternatively to, for example, that with the reference number 169, can also be provided.
- a series of optional valves are each designated with V in Fig. 1. Bypass valves are designated with VB.
- a pressure sensor PS5 for measuring the pressure in the dialysis fluid supply line 104 can be provided. Based on the measured values of the aforementioned optional sensors, in some embodiments the control or regulating device 150 determines the electrolyte and/or liquid balance. Filters F1 and F2 can be connected in series. Filter F1 serves here as an example to produce sufficiently pure dialysis fluid using the mixing device 163, even when using non-pure water, which then flows through the blood filter 303, e.g. using the countercurrent principle.
- the filter F2 serves here as an example to generate sterile or sufficiently filtered substituate from the sufficiently pure dialysis fluid which leaves the first filter F1 by filtering out, for example, pyrogenic substances, which can be safely fed into the patient's extracorporeal blood and thus ultimately into the patient's body.
- the blood treatment device 100 is optionally shown in Fig. 1 as a device for hemo(dia)filtration. However, hemodialysis devices also fall under the present invention, although not specifically shown by means of a figure.
- the arrowheads shown in Fig. 1 generally indicate the direction of flow in each case.
- Fig. 2 shows a blood treatment device 100 according to the invention with a control or regulating device 100 according to the invention in a first embodiment in use.
- the blood pump 101 uses a blood pump 101 to take blood from the patient's vascular access Pa via an arterial (first) connection needle and fed to a blood filter or dialyzer 303 via a first line 301.
- the blood pump 101 can be part of a blood treatment device 100 or integrated into a disposable. Any suitable method can be used for pumping, for example pumping using peristaltic pumps or impeller pumps. Fresenius Medical Care GmbH
- the blood filter 303 can be any unit for carrying out hemodialysis (HD), hemofiltration (HF), hemodiafiltration (HDF), or a combination thereof.
- the device has means for preparing dialysis fluid, for example as shown in Fig.
- the fresh dialysis fluid is conveyed by means of a suitable adjustable flow pump 169 via the dialysis fluid feed line 104 to the blood filter 303, in particular into its dialysis fluid chamber 303a.
- the flow pump 169 can also be viewed as a "loading pump” and also referred to as such, via which the dialysis fluid flow can be adjusted based on the speed of the flow pump 169.
- the balancing device 161 cyclically supplies fresh dialysis fluid via the filter F1 and the dialyzer valve V24, also referred to as the valve, into the dialyzer 303 via a suitable circuit of valves.
- the balancing device 161 alternately ensures that the volume of dialysis fluid flowing into the dialyzer 303 is equal to the volume flowing back via the balancing chambers of the balancing device 161.
- a pressure sensor between the flow pump 169 and the balancing device 161 detects a filled balancing chamber by the increase in pressure and changes the valve position (open/closed) accordingly.
- Fresenius Medical Care GmbH The flow pump 169 ensures that dialysate coming from the dialyzer 303 is fed into the balancing chambers of the balancing device 161.
- the means for preparing dialysis fluid in turn have means for changing the dialysis fluid composition by changing the mixing ratio of the components involved in the online dialysis fluid production, for example as shown in Fig. 1.
- the used dialysate is returned to an optional means for dialysate preparation 160 via a dialysate drain line 102.
- the second flow pump 169 and/or other means for removing fluid by means of ultrafiltration which can be provided in the dialysis fluid supply line 104 or the dialysate drain line 102, can optionally be used for this purpose.
- Means for preferably continuously measuring the dialysate flow can also be contained in one of these lines 102, 104.
- the blood treatment device 100 can further comprise means for branching off a partial flow from the total dialysate for the purpose of substitution according to the specification of the control or regulating device 150, so that an HF or HDF treatment can be carried out in pre- or post-dilution using a balancing device 161 (see Fig. 1).
- the partial flow is here, for example, brought from the flow coming from the balancing device 161 and the filter F1, via the filter F2 into the subsequent fluid line and by means of the substituate pump 111 Fresenius Medical Care GmbH via the pre-dilution line 107a and/or post-dilution line 109a into the extracorporeal blood circuit 300.
- Fig. 1 The partial flow is here, for example, brought from the flow coming from the balancing device 161 and the filter F1, via the filter F2 into the subsequent fluid line and by means of the substituate pump 111 Fresenius Medical Care GmbH via the pre-dilution line 107a and/or post-dilution line 109a into the
- the blood treatment device 100 has two blood-side sensors 402a, 402b and two dialysate-side sensors 400a, 400b, which are arranged upstream and downstream of the blood filter 303.
- These sensors 400a, 400b, 402a, 402b are suitable and intended to determine the concentration of a substance contained in the blood or dialysate, e.g. sodium, or a variable correlated therewith by any method for contact or contactless measurement.
- these can be ion-selective electrodes, conductivity sensors or spectroscopic devices for measuring in the infrared, visible or UV range.
- At least one sensor 400b, 402b is used here, which is arranged downstream of the blood filter 303 on the blood or dialysate side.
- the same or different sensors can be used in such a way that it is possible to calculate the clearance K (or dialysance) of one or more substances or groups of substances by combining or based on the measured values of the different sensors or substance concentrations or quantities correlating with substance concentrations using the control or regulating device 150 according to the invention.
- This can include both methods that do not intervene in the course of the treatment and methods that make variations in the dialysis fluid composition or the flows for the purpose of determining the clearance.
- Fresenius Medical Care GmbH The connection of the sensors 400a, 400b, 402a, 402b to the blood or dialysate side measuring points can be permanently installed in the blood treatment device 100. Alternatively, the sensors can be placed or inserted in whole or in part only when the blood treatment device 100 is prepared.
- the sensors 400a, 400b, 402a, 402b can be part of disposables on the blood and/or dialysate side.
- the connection between the sensors 400a, 400b, 402a, 402b and the control or regulating device 150 can be wired or wireless.
- the control or regulating device 150 is programmed or configured to calculate a clearance K, a dialysis dose Kt or Kt/V based on the measured values of the sensors 400a, 400b, 402a, 402b and other measured and manipulated variables of the blood treatment device 100, in particular blood and dialysate flows. Instead of the currently determined values or in addition to these, values averaged over a time interval can be used.
- the control or regulating device 150 can, e.g. B. using the formulas known or mentioned herein, calculate the blood-side concentrations of the substances of interest, which result both from direct calculation and with the aid of a kinetic model for the exchange across different body compartments, especially during times without dialysate flow.
- Fresenius Medical Care GmbH The variables relating to the clearance K, the dialysis dose Kt or substance concentration can be output to the user or an external observer via a display device 500 and/or a communication device 600. Furthermore, it can be possible to specify a specification for the desired temporal progression of the clearance K using the display device 500 and the communication device 600.
- Fig. 3 shows the temporal sequence of a clearance-controlled change of the dialysate flow during the treatment of a patient Pa by means of a blood treatment device 100 according to the invention comprising a control or regulating device 150 according to the invention in a further embodiment.
- the dialysate flow & ⁇ through the dialyzer 303 can be set to zero in every blood treatment device by switching off the dialysis fluid production or by temporarily diverting the dialysis fluid past the dialyzer 303 (bypass).
- the entire treatment can be divided into ⁇ consecutive sections .
- ⁇ + ⁇ is implemented by switching according to formula 1, i.e. in the simplest case by switching off the flow through the dialysis fluid chamber 303a of the dialyzer 303 after the time period ) ⁇ ⁇ ⁇ , which is also referred to here as the time ⁇ ⁇ can be referred to.
- ⁇ ⁇ and ⁇ are required. These can be estimated from a model of the dialyzer 303 as a function of the dialyzer parameter K 0 A and the flows.
- the total expected clearance is then calculated taking into account the dialysis method used where & 1 is the net ultrafiltration rate, ie the fluid removal by ultrafiltration (in the unit [ml/min]). It should be noted that for ⁇ ⁇ 7 an effective value ⁇ ⁇ 7 ⁇ :11 of the dialyzer parameter must be used, which differs significantly from the manufacturer's data derived from laboratory measurements (e.g. Depner "Dialyzer Performance in the HEMO Study: In Vivo K 0 A and True Blood Flow Determined from a Model of Cross-Dialyzer Urea Extraction", ASAIO Journal 2004) and the real Fresenius Medical Care GmbH blood properties and properties of the bloodstream are taken into account.
- & 1 is the net ultrafiltration rate, ie the fluid removal by ultrafiltration (in the unit [ml/min]). It should be noted that for ⁇ ⁇ 7 an effective value ⁇ ⁇ 7 ⁇ :11 of the dialyzer parameter must be used, which differs significantly from the manufacturer's data derived from laboratory measurements (
- the interval duration is ⁇ . chosen so that a measurement of ⁇ ⁇ , and at & ⁇ ,( > 0 also of ⁇ ( is possible. It is also possible to measure only ⁇ ( or ⁇ ⁇ within the individual intervals and then continue to use the measured value in the following interval, or to adjust the length of the intervals so that a longer interval with clearance measurement is followed by a shorter interval without clearance measurement. At the start of the treatment, an average clearance of ⁇ + ⁇ should be achieved for the duration ⁇ ⁇ .
- the blood treatment device 100 has two discrete dialysate flow settings & I, ⁇ and & I,( , where & I,( can preferably be zero.
- the treatment begins with an initial dialysis fluid flow & I, ⁇ .
- a measurement J ⁇ , ⁇ to determine ⁇ ⁇ and a subsequent determination of ⁇ ⁇ are carried out as soon as possible as shown in Fig. 2 in order to be able to determine a more precise (target) value for ) ⁇ .
- the model in Fig. 4 shows the inter- and intracellular space IC, which has a volume ⁇ LM and a substance concentration Fresenius Medical Care GmbH ⁇ LM .
- the substance concentration ⁇ LM in the intercellular space IC and the substance concentration ⁇ OM of the extracellular space EC, which in turn has a volume ⁇ OM are equalized according to the principle of diffusion.
- the clearance ⁇ ⁇ that occurs during the treatment session a substance is removed from the patient's blood during the treatment session depending on the concentration ⁇ ⁇ .
- the dialysis dose Kt/V can be calculated by rearranging formula 5 from the ratio of the blood-side substance concentration at the beginning of treatment ⁇ ⁇ and the final concentration ⁇ :X ⁇ , where in the 1-pool model ⁇ corresponds to the mean clearance ⁇ during dialysis: (Formula 11) However, since the patient shows a 2-pool behavior, after the end of the treatment session the concentration of substances not contained in the dialysis fluid in the blood increases again, so that ⁇ :N > ⁇ :X ⁇ .
- the dialysis dose calculated from the equilibrated concentration is always lower than the value from the 1-pool model ⁇ ⁇ / ⁇ ⁇ cd , which corresponds to a good approximation to the value obtained by a continuous measurement on the device and the determination of the clearance based on this.
- Fresenius Medical Care GmbH For clinical practice, procedures are offered for converting between ⁇ / ⁇ :N and ⁇ / ⁇ cd (see, for example, Daugirda's "Solute Solver", available at http://www.ureakinetics.org/).
- the equilibrated dialysis dose is not influenced by the intermittent procedure disclosed here, so that the conversion models used remain valid (see Fig. 5a and Fig. 5b).
- concentration curves in the intravascular space EC vascular system
- Fig. 5b shows a numerical simulation of the material concentration curve of a substance such as phosphate, analogous to Fig. 5a, assuming a low intercompartmental clearance of 100 ml/min.
- Fig. 5a shows a possible concentration curve on the dialysate side downstream of the blood filter 303 with intermittent dialysate flow without fluid removal by ultrafiltration.
- the blood-side substance concentration (index “bi”) can be determined from the dialysate-side concentrations (index “di”: dialysis fluid inlet line, “do”: dialysate outlet line) (see e.g. Sargent & Gotch, “Principles and biophysics of dialysis” in “Replacement of renal function by dialysis”) (Formula 12)
- index “di” dialysis fluid inlet line
- dialysate outlet line see e.g. Sargent & Gotch, “Principles and biophysics of dialysis” in “Replacement of renal function by dialysis”
- the concentration curve in the 2-pool model can alternatively be numerically approximated and displayed according to formula 10.
- One possibility for determining the clearance K is the spectroscopic measurement of the concentration curve of a marker substance in the used dialysate, i.e. in the dialysate drain line, or a variable correlated with it (e.g. "Adimea", BBraun) using a sensor 400a and formula 11.
- the concentration in the dialysate flowing out is always lower than in the blood. If the flow through the dialyzer 303 is switched off, the substance concentration of the dialysate still in the dialyzer 303 increases by diffusion to the substance concentration in the patient's blood. If the dialysate flow is completely stopped by sensor 400a, the concentration does not change there. However, if only the dialysate flow through the dialyzer 303 is stopped and the fresh dialysis fluid is instead fed directly to the sensor 400a in a bypass circuit, the concentration there drops to zero or to the concentration in the fresh dialysis fluid.
- Fig. 6b shows a possible concentration curve on the dialysate side downstream of the blood filter 303 with intermittent dialysate flow with fluid removal by ultrafiltration.
- the dialysate at the sensor 400a is displaced by the ultrafiltrate if the UF volume flow is sufficiently high, so that the same concentration is ultimately present here as in the blood, which can therefore be measured directly.
- the volume removal required for this corresponds approximately to the dialysate-side volume of the dialyzer 303, i.e. approximately 100 ml. If this method is to be used for measuring the blood-side concentration on the dialysate side, it is advantageous to increase the ultrafiltration rate during the time when the dialysate is not flowing.
- the dialyzer volume can be obtained by input, for example by means of the communication device 600, or by device-side measurements, e.g. the running time of an upstream conductivity change until it reaches sensor 400a.
- the system can then decide whether a Fresenius Medical Care GmbH has promoted a sufficiently high ultrafiltration volume and thus a reliable determination of the blood-side concentration is possible.
- the method described here for measuring substance concentrations can also be used in the case when the substance to be determined is already in the fresh dialysis fluid.
- the specification of the mean clearance ⁇ + to be achieved in the individual time intervals can be based on patient-specific or general empirical values or based on kinetic models for the change in the Fresenius Medical Care GmbH substance concentration in the various body compartments.
- a patient may know that the disequilibrium syndrome only occurs if the diffusive clearance exceeds a certain limit value, e.g. 100 ml/min, in the first 30 minutes of dialysis.
- This limit value determined from clinical experience, may also depend on the day of the week and may differ from that of other days, particularly on the day after the long dialysis-free interval (e.g. Monday or Tuesday).
- This or similar information can be entered via the communication device 600 or made available to the control or regulating device according to the invention for the calculations.
- the time-dependent concentration difference between the compartments and thus, for example, the osmotic pressure can be calculated using multi-compartment models, analogous to those explained here, for example, as a 2-pool model, which may contain the brain volume as an additional compartment.
- the target clearance of the dialysis system can then be calculated in such a way that a critical concentration difference or a critical osmotic pressure is not exceeded. This applies in particular to molecules such as urea or ethanol.
- the limiting factor can be a critical rate of change in the substance concentration.
- plasma sodium for example, there are empirical values from Fresenius Medical Care GmbH of the intensive care unit (e.g. daily change ⁇ 6 mmol/L).
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Abstract
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Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE102023100665.7A DE102023100665A1 (de) | 2023-01-12 | 2023-01-12 | Steuer- oder Regelvorrichtung für eine Blutbehandlungsvorrichtung zur Regelung der Clearance bei der Dialyse |
| PCT/EP2024/050445 WO2024149785A1 (de) | 2023-01-12 | 2024-01-10 | Steuer- oder regelvorrichtung fuer eine blutbehandlungsvorrichtung zur regelung der clearance bei der dialyse |
Publications (1)
| Publication Number | Publication Date |
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| EP4648816A1 true EP4648816A1 (de) | 2025-11-19 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EP24700868.3A Pending EP4648816A1 (de) | 2023-01-12 | 2024-01-10 | Steuer- oder regelvorrichtung fuer eine blutbehandlungsvorrichtung zur regelung der clearance bei der dialyse |
Country Status (6)
| Country | Link |
|---|---|
| EP (1) | EP4648816A1 (de) |
| JP (1) | JP2026507410A (de) |
| CN (1) | CN120569229A (de) |
| AU (1) | AU2024208709A1 (de) |
| DE (1) | DE102023100665A1 (de) |
| WO (1) | WO2024149785A1 (de) |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE19746367C2 (de) * | 1996-11-30 | 1999-08-26 | Fresenius Medical Care De Gmbh | Verfahren zur in-vivo-Bestimmung von Parametern der Hämodialyse und Vorrichtung zur Durchführung des Verfahrens |
| DE102010047215A1 (de) * | 2010-09-29 | 2012-03-29 | Bbraun Avitum Ag | Dialysat-Profiling gesteuert durch UV-Kontrolle |
| DE102012109858A1 (de) * | 2012-10-16 | 2014-04-17 | B. Braun Avitum Ag | Dialyseoptimierungsverfahren |
| DE102014011699B4 (de) * | 2014-08-07 | 2023-11-02 | Fresenius Medical Care Deutschland Gmbh | Vorrichtung zur Ermittlung eines optimalen Dialysatflusses für eine extrakorporale Blutbehandlung mit einer extrakorporalen Blutbehandlungsvorrichtung |
-
2023
- 2023-01-12 DE DE102023100665.7A patent/DE102023100665A1/de active Pending
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- 2024-01-10 EP EP24700868.3A patent/EP4648816A1/de active Pending
- 2024-01-10 JP JP2025540122A patent/JP2026507410A/ja active Pending
- 2024-01-10 AU AU2024208709A patent/AU2024208709A1/en active Pending
- 2024-01-10 CN CN202480007399.8A patent/CN120569229A/zh active Pending
- 2024-01-10 WO PCT/EP2024/050445 patent/WO2024149785A1/de not_active Ceased
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| AU2024208709A1 (en) | 2025-08-28 |
| DE102023100665A1 (de) | 2024-07-18 |
| CN120569229A (zh) | 2025-08-29 |
| JP2026507410A (ja) | 2026-03-04 |
| WO2024149785A1 (de) | 2024-07-18 |
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