EP4326361A1 - Procédé de commande d'un dispositif de traitement du sang et dispositifs associés - Google Patents

Procédé de commande d'un dispositif de traitement du sang et dispositifs associés

Info

Publication number
EP4326361A1
EP4326361A1 EP22724073.6A EP22724073A EP4326361A1 EP 4326361 A1 EP4326361 A1 EP 4326361A1 EP 22724073 A EP22724073 A EP 22724073A EP 4326361 A1 EP4326361 A1 EP 4326361A1
Authority
EP
European Patent Office
Prior art keywords
blood
treatment device
pump
blood treatment
transmembrane pressure
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
Application number
EP22724073.6A
Other languages
German (de)
English (en)
Inventor
Pascal Kopperschmidt
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Fresenius Medical Care Deutschland GmbH
Original Assignee
Fresenius Medical Care Deutschland GmbH
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Fresenius Medical Care Deutschland GmbH filed Critical Fresenius Medical Care Deutschland GmbH
Publication of EP4326361A1 publication Critical patent/EP4326361A1/fr
Pending legal-status Critical Current

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
    • A61M1/1603—Regulation parameters
    • 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
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3622—Extra-corporeal blood circuits with a cassette forming partially or totally the blood circuit
    • A61M1/36226—Constructional details of cassettes, e.g. specific details on material or shape
    • A61M1/362263—Details of incorporated filters
    • A61M1/362264—Details of incorporated filters the filter being a blood filter
    • 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
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3626—Gas bubble detectors
    • 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
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3627—Degassing devices; Buffer reservoirs; Drip chambers; Blood filters
    • A61M1/3629—Degassing devices; Buffer reservoirs; Drip chambers; Blood filters degassing by changing pump speed, e.g. during priming
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/70—General characteristics of the apparatus with testing or calibration facilities
    • A61M2205/702—General characteristics of the apparatus with testing or calibration facilities automatically during use

Definitions

  • the present invention relates to a method for controlling a blood treatment device according to claim 1, a control or regulating device according to claim 9 and a blood treatment device according to claim 10.
  • the present invention also relates to a digital storage medium according to claim 15, a computer program product according to claim 16 and a computer program according to claim 17 or according to the preambles or generic terms of these claims.
  • Various types of blood treatment devices are known from practice. They include, for example, devices for hemodialysis, hemofiltration and hemodiafiltration.
  • the blood flows through a blood treatment unit in an extracorporeal blood circuit.
  • the blood treatment unit is a dialyzer or filter which, to put it simply, is separated into a blood chamber and a dialysis fluid chamber by a semi-permeable membrane.
  • the blood flows through the blood chamber while a dialysis fluid flows through the dialysis fluid chamber.
  • Air or microbubbles in extracorporeal circuits downstream of a venous air separating chamber can lead to gas embolism in the patient's body. Embolism can block vessels and cause ischemia.
  • the venous air separation chamber is located in the venous blood tubing system. It partially reduces the flow rate within the extracorporeal circuit, so that gas bubbles rise counter to gravity according to the Archimedean principle and can be separated through an opening in an upper area of the venous air separation chamber.
  • the venous system downstream of the air separation chamber is checked for the presence of air, e.g. B. in the form of microbubbles, monitored in the extracorporeal flowing blood. If the sensor detects the presence of air, an air bubble alarm will sound, interrupting the patient's blood treatment. After the responsible person has eliminated the cause of the air bubble alarm, the blood treatment can be continued.
  • air e.g. B. in the form of microbubbles
  • a control or regulating device (in short: control device that can optionally also regulate) is to be proposed with which the method can be brought about or initiated or carried out.
  • further devices suitable for carrying out the method in particular a blood treatment device, a digital storage medium, a computer program product and a computer program.
  • the object according to the invention is achieved by the method with the features of claim 1. It is also achieved by means of the control or regulating device with the features of claim 9, the blood treatment device with the features of claim 10, by means of the digital storage medium with the features of claim 15, the computer program product with the features of claim 16 and the computer program with the features of claim 17.
  • a method for controlling a blood treatment device having a blood pump, an air bubble detector and a pump for conveying dialysis liquid and/or dialysate on its hydraulic side.
  • the method is initiated or performed during an extracorporeal blood treatment session, during which the blood treatment device is connected to an extracorporeal blood circuit and to a blood filter, which in turn has a semi-permeable membrane.
  • the method includes, for. B. after detecting air bubbles or air pockets in the extracorporeal blood circuit, or z. B. after an air bubble alarm, stopping the blood pump or reducing its output provided immediately before detecting the air bubbles, and generating a negative transmembrane pressure across the semi-permeable membrane of the blood filter away.
  • This negative transmembrane pressure can be achieved by appropriately controlling the pump on the hydraulic side while the blood pump is stopped or its delivery rate is reduced.
  • the transmembrane pressure can be measured in a variety of ways and its existence can be determined directly or indirectly.
  • Air bubbles or air inclusions in the extracorporeal blood circuit can be detected using the air bubble detector.
  • the air bubble detector can be suitable or configured to trigger an air bubble alarm (alternatively: gas alarm) as a result of the detection of gas, air or air bubbles, which in turn causes the method according to the invention to be initiated or carried out.
  • an air bubble alarm alternatively: gas alarm
  • Air bubbles or air inclusions can be detected, for example, by an air bubble alarm, by the fulfillment of conditions that trigger an air bubble alarm or are sufficient to trigger an air bubble alarm.
  • a control or regulating device is also proposed, which is configured to initiate, carry out, control and/or regulate the method according to the invention—in particular automatically—in cooperation with a blood treatment device or its facilities or devices, in particular as disclosed herein .
  • Interaction can be or include driving, controlling or regulating.
  • Interaction may be or require a signal connection.
  • a blood treatment device which in each case has at least one blood pump, an air bubble detector, a pump for conveying dialysis fluid and/or dialysate and a control or regulating device, in particular a control or regulating device according to the invention, which in turn is configured to cause a method according to the invention to be carried out is, has or is connected to such inputs and devices in each case.
  • the blood treatment device according to the invention can have a correspondingly suitable and/or configured facility or device such as a Legs
  • An inventive, in particular digital, in particular non-volatile, storage medium (here also referred to as a carrier), in particular in the form of a diskette, RAM, ROM, CD, hard drive, DVD, USB stick, flash card, SD card or EPROM, in particular with electronically or optically readable control signals, can be configured in such a way in order to configure a control device to form a control or regulating device with which the method according to the invention described herein can be initiated or carried out.
  • the digital Storage medium can be configured to configure a blood treatment device to form a blood treatment device according to the invention, with which the method according to the invention described herein can be effected or executed.
  • a computer program product according to the invention has a program code that is volatile or stored on a machine-readable carrier, by means of which a control device is configured into a control or regulating device, by means of which the method according to the invention described herein can be initiated or carried out.
  • a blood treatment device can be configured by means of the computer program product in such a way that the method according to the invention described herein can be effected or executed.
  • machine-readable medium refers to a medium that contains data or information that can be interpreted by software and/or hardware.
  • the medium can be a data carrier such as a floppy disk, a CD, DVD , a USB stick, a flash card, an SD card, an EPROM and the like.
  • a computer program according to the invention has a program code through which a control or
  • Control device or a blood treatment device is configured in such a way that the method according to the invention described herein can be initiated or carried out.
  • a computer program product can be, for example, a computer program stored on a carrier, an embedded system as a comprehensive system with a computer program (e.g. an 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, run, stored, executed or developed.
  • a computer program stored on a carrier
  • an embedded system as a comprehensive system with a computer program
  • a network of computer-implemented computer programs e.g. client/server system , cloud computing system, etc.
  • a computer program can be understood, for example, as a physical, salable software product which has a program.
  • a venous air separation chamber or an air separation chamber can also be a venous blood chamber, a venous bladder chamber or a venous drip chamber.
  • the subject matter of the invention comprises one or more features in a particular embodiment
  • the subject matter according to the invention expressly does not have this or these features in other embodiments that are also according to the invention, e.g. B. in the sense of a disclaimer.
  • the contrary embodiment for example formulated as a negation, is also disclosed.
  • Embodiments according to the invention can have one or more of the features mentioned above and/or below in any technically possible combination.
  • a negative transmembrane pressure is generated across the semi-permeable membrane with the venous tube clamp fully or partially closed.
  • the method comprises, as a further step, opening the venous hose clamp when a negative transmembrane pressure has already been generated or is present, while maintaining a negative transmembrane pressure.
  • Plasma water transfer takes place and the blood in the dialyzer is hemoconcentrated.
  • the fluid volume pumped into the hydraulic system or shifted from the extracorporeal blood circuit to the hydraulic side via the semi-permeable membrane due to the pressure difference is replaced by blood that is counter to (herein also: retrograde) its usual direction of flow within the blood circuit via the venous part of the tubing system from the latter and from the vascular system of the patient is caused to flow by the hemoconcentration and the negative pressure.
  • the air bubbles or air inclusions (e.g. gas and micro-bubbles) in the line are transported back retrograde into the venous air separation chamber and separated there, mostly to the environment.
  • the venous tube clamp is opened when a pressure sensor of the blood treatment device has determined that a negative minimum transmembrane pressure has been reached.
  • a negative transmembrane pressure is generated by the pump on the hydraulic side of the blood treatment device, while an optional substituate pump of the blood treatment device is stopped or not pumping.
  • the creation or maintenance of the negative transmembrane pressure is terminated as soon as a negative transmembrane pressure of about
  • the conveying by means of the pump on the hydraulic side of the blood treatment device for generating a negative transmembrane pressure is terminated after the air bubble detector no air bubbles or Air inclusions are no longer detected and/or there is no longer an air bubble alarm and/or at least 30 to 60 ml of blood has been pumped retrograde.
  • the pump for delivering dialysis liquid and/or dialysate is an optionally provided ultrafiltration pump.
  • the blood treatment device according to the invention is connected to an extracorporeal blood circuit and a blood filter, the blood filter having a semi-permeable membrane.
  • the extracorporeal blood circuit is a blood tubing set and/or a blood cassette or has a blood tubing set and/or a blood cassette.
  • the pump for conveying dialysis liquid and/or dialysate is an ultrafiltration pump.
  • the blood treatment device is designed as a hemodialysis device, hemofiltration device,
  • Hemodiafiltration device or as a device for performing a separation process.
  • this includes determining whether the generated negative transmembrane pressure or its amount is within predetermined limits, exceeds or falls below a limit value, a minimum value exceeds and/or does not exceed a maximum value. This can be done based on at least one criterion (limit, range, maximum, etc.), which z. B. can be stored in a storage device, such as the blood treatment device.
  • the method includes only emitting or outputting an acoustic and/or optical or other signal-based air bubble alarm if, during or after the process according to the invention, there is still or again a state that already gave rise to an air bubble alarm before the start of the method according to the invention for the responsible person and/or the blood treatment device. Provision can thus be made for the user to be informed optically and/or acoustically about the presence of an air bubble alarm and/or to only interrupt the blood treatment automatically if, after detecting air bubbles, the removal of the detected air by means of the method according to the invention e.g. B. according to the features of claim 1, was not successful.
  • the pump is a displacement pump, in particular a diaphragm pump, eccentric diaphragm pump, peristaltic pump, roller pump or piston pump.
  • the extracorporeal blood circuit has no venous air separation chamber, which upside down or inverted, or in which a narrower (or smaller diameter or cross-sectional area) end of the air separating chamber is higher than a larger (or larger diameter or cross-sectional area) end thereof.
  • the application of the negative transmembrane pressure is not intended to remove air bubbles directly from the air separating chamber and thus from the extracorporeal blood circuit, bypassing the blood filter.
  • the method is not a method of draining an extracorporeal blood treatment device.
  • the negative transmembrane pressure is applied while the blood pump is stopped and/or not pumping.
  • Another advantage of the present invention may be that the patient does not lose blood by discarding whole blood, e.g. B. in the aforementioned saline bag suffers. This also advantageously contributes to patient well-being and patient safety.
  • a fully automated and hygienically an method for treating air bubble alarms in the venous line with induced separation of the microbubbles can be made available. This can advantageously help to reduce personnel costs and increase patient safety.
  • Fig. 1 shows a schematically simplified one
  • Fig. 2 shows a part of the schematically simplified
  • Fig. 3 shows, in a schematically simplified manner, the course of the method according to the invention.
  • Fig. 1 shows a schematically simplified fluid line structure of a blood treatment device 100 according to the invention in a first embodiment.
  • the blood treatment device 100 is connected to an extracorporeal blood circuit 300, which can be used for treatment by means of double-needle access, or using z.
  • an additional Y-connector (reference symbol Y) as shown in Fig. 1 can be connected by means of single-needle access to the vascular system of the patient, not shown.
  • the blood circuit 300 can optionally be present in portions thereof in or on a blood cassette. Pumps, actuators and/or valves in the area of the blood circuit 300 can be connected to the blood treatment device 100 according to the invention or to one of these, e.g. B. included control or regulating device 150 connected.
  • the blood circuit 300 has an arterial hose clamp or patient hose clamp 302 as a first hose clamp and an arterial connection needle of an arterial section or an arterial patient line, an arterial line section, a blood sampling line or the first line 301 (or is connected to it).
  • the blood circuit 300 further comprises (or is connected to) a venous hose clamp or patient hose clamp 306 as a second hose clamp and a venous connection needle of a venous section, a venous patient line, a venous line section, a blood return line or second line 305 .
  • a blood pump 101 is provided in or on the first line 301, a substituate pump 111 is connected to a dialysis fluid supply line 104 for conveying fresh dialysis fluid, which is filtered (substituate) in a further filter stage (F2).
  • a substituate line 105 may be fluidly connected to the inflow line 104 .
  • substituate can be introduced by pre-dilution, via a pre-dilution valve 107, or by post-dilution, via a post-dilution valve 109, via associated lines 107a or 109a into line sections, for example into the arterial line section 301 or into the venous line section 305 (here between a Blood chamber 303b of a blood filter 303 and a venous Air separation chamber of the blood circuit 300) are introduced.
  • the blood filter 303 has the blood chamber 303b connected to the arterial line section 301 and to the venous line section 305 .
  • 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 a dialysate outlet line 102 leading away from the dialysis fluid chamber 303a and carrying dialysate, ie used dialysis fluid.
  • Dialysis fluid chamber 303a and blood chamber 303b are separated from one another by a mostly semi-permeable membrane 303c. It represents the separating sheath between the blood side with the extracorporeal blood circuit 300 and the machine side with the dialysis liquid or dialysate circuit, which is shown on the left of the membrane 303c in FIG.
  • FIG. 1 includes an air bubble detector 315 for detecting air and/or blood, preferably in the venous line section 305, e.g. B. at the location shown.
  • FIG. 1 optionally also includes one or two pressure sensors PSI (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.
  • Further pressure sensors can be provided, e.g. the pressure sensor PS3 downstream of the venous air separation chamber 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 only one of the two blood lines 301, 305 .
  • the arrangement of Figure 1 also includes an optional detector 319 for detecting air bubbles and/or blood.
  • An addition point 325 for heparin can optionally be provided.
  • An optional mixing device 163 is shown on the left in Fig. 1, which from the containers A (for A concentrate via the concentrate supply 166) and B (for B concentrate via the concentrate supply 168) a predetermined mixture for the respective solution for use by the blood treatment device 100 provides.
  • the solution contains water from the water source 155 (online, e.g. as reverse osmosis water or from bags), which e.g. B. in the heater 162 is heated.
  • a pump 171 which may be referred to as a concentrate pump or sodium pump, may be fluidly connected to and/or pump, if provided, from the mixer 163 and a source of sodium, such as container A.
  • An optional pump 173 associated with container B, such as for bicarbonate, can be seen.
  • a drain 153 for the effluent can also be seen in FIG. 1 .
  • An optional heat exchanger 157 and a first flow pump 159 suitable for degassing complete the arrangement shown.
  • the optional pressure sensor PS4 downstream of the blood filter 303 on the water side but preferably upstream of the ultrafiltration pump 131 in the dialysate discharge line 102 can be provided for measuring the filtrate pressure or membrane pressure of the blood filter 303.
  • Blood leaving the blood filter 303 flows through a venous air separation chamber 329, which is a
  • venting device 318 can be in fluid communication with the pressure sensor PS3.
  • the exemplary arrangement shown in FIG. 1 has the control or regulating device 150 . It can be in a wired or wireless signal connection with any of the components mentioned here—at least or in particular with the blood pump 101—for controlling or regulating the blood treatment device 100 .
  • the optional device for online mixing of the dialysis fluid it is possible to vary its sodium content within certain limits, controlled by the control or regulating device 150 .
  • the measured values determined by means of conductivity sensors 163a, 163b can be included for this purpose. Should there be an adjustment the sodium content of the dialysis fluid
  • the blood treatment device 100 includes means for conveying fresh dialysis fluid and dialysate on the so-called hydraulic side of the blood treatment device 100.
  • a first valve 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 z. B. provided downstream of the blood filter 303, which promotes dialysate to the drain 153.
  • a second valve can be provided between the blood filter 303 and the second flow pump 169, which opens or closes the outlet on the outlet side.
  • the blood treatment device 100 optionally includes a device 161 for balancing the flow flowing into and out of the dialyzer 303 on the machine side.
  • the device 161 for balancing is preferably arranged in a line area between the first flow pump 159 and the second flow pump 169 .
  • the blood treatment device 100 further comprises means for the exact removal of a volume of liquid specified by the user and/or by the control or regulating device 150 from the balanced circuit, such as the ultrafiltration pump 131.
  • Sensors such as the optional conductivity sensors 163a, 163b are used to determine the conductivity, which is temperature-compensated in some embodiments, and the liquid flow upstream and downstream of the dialyzer 303.
  • Temperature sensors 165a, 165b can be provided individually or in groups. According to the invention, temperature values supplied by them can be used to determine a temperature-compensated conductivity.
  • An optional compressed air source 175, for example in the form of a compressor, can be provided on the machine side upstream of the blood filter 303.
  • a leakage sensor 167 is optionally provided. Alternatively, it can also be provided elsewhere.
  • V in FIG. Bypass valves are marked with VB.
  • control or regulating device 150 determines the electrolyte and/or liquid balance based on the measured values of the aforementioned, optional sensors.
  • Filter F1 and F2 can be connected in series.
  • the filter F1 is used here, for example, by means of the mixing device 163 itself using non-pure Water to produce sufficiently pure dialysis fluid, which then z. B. in the countercurrent principle, through the blood filter 303 flows.
  • the filter F2 is used here, for example, to remove, by filtering z. B. pyrogenic substances to generate sterile or sufficiently filtered substituate, which can safely be fed to the extracorporeal flowing blood of the patient and thus ultimately the patient's body.
  • the blood treatment device 100 shown in FIG. 1 may be a hemofiltration device, a hemodiafiltration device, or a hemodialysis device.
  • the present invention is not limited to the embodiment described above, which is merely illustrative.
  • Figure 1 generally indicate the direction of flow in Figures 1 and 2, respectively.
  • the arterial line section 301 and the venous line section 305 can be part of a blood tubing set or form this.
  • FIG. 2 shows a schematically simplified part of the blood treatment device 100 of FIG. 1, namely the part to the right of the dashed line A, during the method according to the invention.
  • FIG. 2 shows a schematically simplified part of the blood treatment device 100 of FIG. 1, namely the part to the right of the dashed line A, during the method according to the invention.
  • FIG. 2 shows a schematically simplified part of the blood treatment device 100 of FIG. 1, namely the part to the right of the dashed line A, during the method according to the invention.
  • the method according to the invention leads to a reversal of flow in the venous line section 305, as indicated by the direction of the arrows and arrowheads which is in the opposite direction in comparison to FIG. 1, to prevent or noticeably reduce the flow between the patient and the venous hose clamp 306 and for liquid to pass from the blood chamber 303b into the dialysis liquid chamber 303a, as also indicated by arrows.
  • Fig. 3 schematically shows the sequence of the method according to the invention.
  • the blood treatment device 100 which is to be controlled using the method according to the invention, has a blood pump 101, an air bubble detector 315 and a pump for conveying dialysis liquid and/or dialysate on the hydraulic side of the blood treatment device 100 (see Fig. 1 and Fig. 2).
  • the method is intended to be performed during an extracorporeal blood treatment session, ie intradialytically.
  • the blood treatment device 100 is connected to an extracorporeal blood circuit 300 and to a blood filter 303 .
  • the blood filter 303 in turn has a semi-permeable membrane 303c.
  • the method optionally includes as M1 the step of detecting air bubbles or air inclusions in the extracorporeal blood circuit 300 or detecting an air bubble alarm.
  • the air bubbles or air inclusions can be detected using the air bubble detector 315 .
  • this can be suitably configured to trigger an air or gas bubble alarm as a result of the detection of air bubbles.
  • step M1 does not belong to the method according to the invention, but is regarded as a prerequisite for carrying out the same.
  • Method step M2 represents a stopping of the blood pump 101 or, alternatively, a reduction in the pumping capacity provided immediately before air bubbles are detected.
  • the optional method step M3 stands for a complete or partial closing of the venous hose clamp 306.
  • Method step M5 represents an opening of the venous hose clamp 306 when the negative transmembrane pressure P TM has already been generated while maintaining a negative transmembrane pressure PTM or with a negative transmembrane pressure PTM.
  • Hose clamp 306 is opened when a negative minimum transmembrane pressure P TM-min has been determined, for example by means of at least one pressure sensor PS4 of blood treatment device 100.
  • the pressure sensor PS3 (venous sensor) or the pressure sensor PS2 are used to evaluate the pressure situation.
  • the determined pressures can be monitored in order to detect a drop in pressure and to open the venous tube clamp 306 accordingly.
  • the operating pressure during treatment is mostly around 320 mmHg for PS3 and around 300 mmHg for PS2.
  • a (transmembrane) plasma water transfer takes place via the membrane and the blood is hemoconcentrated in the dialyzer.
  • the volume pumped into the hydraulic system is replaced by the blood flowing out of the patient via the venous hose system in the opposite direction to the usual flow.
  • the air bubbles or air pockets are conveyed back into the venous air separation chamber and separated there, for example to the environment.
  • a negative transmembrane pressure PTM is generated by the pump, while an optional substituate pump 111 of
  • Blood treatment device 100 is stopped or not promoting.
  • Method step M6 stands for ending the generation or maintenance of the negative transmembrane pressure PTM as soon as a predetermined negative transmembrane pressure PTM, which is, for example, in the range between -300 mmHg and -500 mmHg, is reached or by means of the generated transmembrane pressure PTM , or due to this Volume of at least 30 to 60 ml of blood in the direction of an arterial needle or a venous air separation chamber 329 was conveyed.
  • a predetermined negative transmembrane pressure PTM which is, for example, in the range between -300 mmHg and -500 mmHg, is reached or by means of the generated transmembrane pressure PTM , or due to this Volume of at least 30 to 60 ml of blood in the direction of an arterial needle or a venous air separation chamber 329 was conveyed.
  • Air bubble detector 315 no longer detects air bubbles or air pockets and/or no air bubble alarm is present.
  • Blood treatment device 100 can be the ultrafiltration pump 131, for example.
  • Reference List
  • PSI arterial pressure sensor (optional)
  • PS2 arterial pressure sensor (optional)
  • PS4 pressure sensor for measuring the filtrate pressure (optional) PTM negative transmembrane pressure

Abstract

L'invention concerne un procédé de commande d'un dispositif de traitement du sang (100) en cas de présence de bulles d'air ou d'inclusions d'air dans un circuit sanguin extracorporel (300) relié au dispositif de traitement du sang (100), lesquelles ont été détectées au moyen d'un détecteur de bulles d'air (315). L'invention concerne en outre un dispositif de commande ou de régulation (150) ainsi qu'un dispositif de traitement du sang (100) permettant de mettre en œuvre ledit procédé, un support d'enregistrement numérique, un produit programme d'ordinateur ainsi qu'un programme d'ordinateur.
EP22724073.6A 2021-04-22 2022-04-21 Procédé de commande d'un dispositif de traitement du sang et dispositifs associés Pending EP4326361A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102021110331.2A DE102021110331A1 (de) 2021-04-22 2021-04-22 Verfahren zum Steuern einer Blutbehandlungsvorrichtung, und Vorrichtungen
PCT/EP2022/060501 WO2022223669A1 (fr) 2021-04-22 2022-04-21 Procédé de commande d'un dispositif de traitement du sang et dispositifs associés

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EP4326361A1 true EP4326361A1 (fr) 2024-02-28

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EP22724073.6A Pending EP4326361A1 (fr) 2021-04-22 2022-04-21 Procédé de commande d'un dispositif de traitement du sang et dispositifs associés

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EP (1) EP4326361A1 (fr)
JP (1) JP2024514600A (fr)
KR (1) KR20230175224A (fr)
CN (1) CN117202948A (fr)
AU (1) AU2022260476A1 (fr)
CA (1) CA3217042A1 (fr)
DE (1) DE102021110331A1 (fr)
WO (1) WO2022223669A1 (fr)

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DE102022119819A1 (de) 2022-08-05 2024-02-08 Fresenius Medical Care AG & Co. KGaA Blutbehandlungsvorrichtung

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5252213A (en) 1989-06-20 1993-10-12 University Of Washington Dry dialysate composition
US7615028B2 (en) 2004-12-03 2009-11-10 Chf Solutions Inc. Extracorporeal blood treatment and system having reversible blood pumps
US20120065482A1 (en) 2005-04-08 2012-03-15 Mark Ries Robinson Determination of blood pump system performance and sample dilution using a property of fluid being transported
DE102011110472A1 (de) * 2011-07-29 2013-01-31 Fresenius Medical Care Deutschland Gmbh Verfahren sowie Vorrichtungen zum Ablösen von Gasansammlungen von einem Gerinnselfänger eines extrakorporalen Blutkreislaufs
US9173987B2 (en) 2013-02-01 2015-11-03 Medtronic, Inc. Degassing module for a controlled compliant flow path
DE102016107026A1 (de) * 2016-04-15 2017-10-19 B. Braun Avitum Ag Verfahren zur Entleerung eines Geräts zur extrakorporalen Blutbehandlung

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KR20230175224A (ko) 2023-12-29
DE102021110331A1 (de) 2022-10-27
CN117202948A (zh) 2023-12-08
JP2024514600A (ja) 2024-04-02
CA3217042A1 (fr) 2022-10-27
AU2022260476A1 (en) 2023-10-12
WO2022223669A1 (fr) 2022-10-27

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