EP4142823A1 - Dispositif de traitement de sang extracorporel - Google Patents

Dispositif de traitement de sang extracorporel

Info

Publication number
EP4142823A1
EP4142823A1 EP21721430.3A EP21721430A EP4142823A1 EP 4142823 A1 EP4142823 A1 EP 4142823A1 EP 21721430 A EP21721430 A EP 21721430A EP 4142823 A1 EP4142823 A1 EP 4142823A1
Authority
EP
European Patent Office
Prior art keywords
flow path
pressure
downstream
section
upstream
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
EP21721430.3A
Other languages
German (de)
English (en)
Inventor
Alfred Gagel
Burkard KELLER
Peter KLÖFFEL
Martin Thys
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 EP4142823A1 publication Critical patent/EP4142823A1/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
    • 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
    • A61M1/1621—Constructional aspects thereof
    • A61M1/165—Constructional aspects thereof with a dialyser bypass on the dialysis fluid line
    • 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
    • A61M1/3643—Priming, rinsing before or after use
    • A61M1/3644—Mode of operation
    • 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

Definitions

  • the invention relates to an extracorporeal blood treatment device which has a blood treatment unit which is divided by a semipermeable membrane into a first compartment, which is part of a fluid system, and a second compartment, which is part of an extracorporeal blood circuit.
  • the invention also relates to a method for operating such a blood treatment device.
  • the known dialysis devices have an extracorporeal blood circuit and a dialysis fluid system.
  • the dialysis fluid system comprises a dialysis fluid supply line which leads from a dialysis fluid source to the dialysis fluid chamber of a dialyzer, and a dialysis fluid discharge line which leads from the dialysis fluid chamber of the dialyzer to a drain.
  • the extracorporeal blood circuit comprises an arterial blood line which leads from an arterial puncture point of the patient to the blood chamber, and a venous blood line which leads from the blood chamber to a venous puncture point of the patient. While the dialysis fluid flows through the dialysis fluid chamber of the dialyzer, substances are transported between the blood chamber and the dialysis fluid chamber via the semipermeable membrane of the dialyzer.
  • the fluid system of the known extracorporeal blood treatment devices is generally such that a fresh medical treatment fluid at a predetermined flow rate, for example dialysis fluid, flows into the first compartment of the blood treatment unit and used treatment fluid flows from the first compartment of the blood treatment unit into a drain.
  • the fluid system of the known blood treatment devices therefore generally comprises a first flow path having at least one fluid line, which is used as a flow path for supplying a fresh treatment fluid from a fluid source to the first Compartment of the blood treatment unit is formed, and a second flow path having at least one fluid line, which is formed as a flow path for discharging a used treatment fluid from the first compartment of the blood treatment unit to a drain.
  • the first and second flow paths of the known blood treatment devices are separated from one another.
  • the fluid system of the known blood treatment devices generally has additional flow paths which are each required for a particular operating mode.
  • These special operating modes include, for example, filling the blood treatment device with a cleaning agent and / or disinfectant or preparing the blood tubing system for the blood treatment.
  • a special operating mode is also the creation of a flow connection between the first and second flow paths, bypassing the blood treatment unit (bypass) in preparation for the blood treatment or during the blood treatment in the event of a malfunction.
  • the liquid systems of the known blood treatment devices contain valve devices, which can include one or more shut-off devices, as well as a control unit for controlling the valve device in such a way that the valve device assumes one operating position for one operating mode and another operating position for another operating mode.
  • the flow paths for the special operating modes comprise an upstream section upstream of a valve device having at least one valve and a downstream section downstream of the valve device, the valve device being designed such that in a first operating position of the valve device there is a fluid connection between the upstream section and the downstream section of the Flow path is established and the fluid connection is interrupted in a second operating position of the valve device.
  • the downstream section of the flow path for a particular operating mode with the second flow path in There is a flow connection, so that a liquid, for example dialysis liquid, can flow from the upstream section via the second flow path directly into the drain if the flow connection in the flow path is not interrupted.
  • a dialysis device which has two separate flow paths in which fresh and used dialysis fluid flow during the blood treatment is known, for example, from EP 2 844 313 B1.
  • the fluid system of the dialysis machine has a valve device comprising several shut-off elements.
  • the invention is based on the object of providing an additional safety measure in order to further reduce the risk of contamination of the blood treatment device as a result of a used liquid flowing into a fresh liquid.
  • the blood treatment device has a valve device which is provided in a flow path for a special operating mode.
  • the valve device is designed such that in a first operating position of the valve device a fluid connection is established between an upstream section and a downstream section of the flow path for a particular operating mode and the fluid connection is interrupted in a second operating position of the valve device.
  • the blood treatment device has a pressure-based control device which interacts with a control unit for actuating the valve device and which is designed such that a fluid connection between the upstream section and the downstream section of the flow path for a particular operating mode can only be established if the pressure-based control device has one Establishes operating state in which it is ensured that in the flow path for a particular operating mode liquid flows in the direction of a flow path leading to a drain. This ensures that the liquid in question can only flow into the flow path that leads to the drain, but not into another flow path in which there is fresh treatment liquid.
  • a preferred embodiment provides that the pressure-based control device an upstream pressure gauge for measuring the upstream pressure in the upstream section of the flow path for a particular operating mode and a downstream pressure meter for measuring the downstream pressure in the downstream section of the flow path and one of the measurement signals of the upstream and downstream Has downstream pressure gauge receiving evaluation unit.
  • the evaluation unit is configured in such a way that the upstream pressure is compared with the downstream pressure, in which case an operating state is inferred in which it is ensured that liquid flows in the direction of the second flow path when the upstream pressure is higher than the downstream pressure.
  • the control unit and / or evaluation unit can be part of the central control and computing unit of the blood treatment device.
  • the pressure can be measured with a pressure gauge, which is arranged on the upstream or downstream section of the flow path for the particular operating mode, or with a pressure gauge, which is arranged on a liquid line that is in fluid connection with the section in question. Pressure gauges are preferably used which are already provided in conventional blood treatment devices for monitoring the blood treatment.
  • an acoustic, visual or tactile alarm can be given in order to notify the medical staff of this and to react accordingly.
  • control unit of the valve device or the central control and computing unit of the blood treatment device can be configured in such a way that after receiving a signal from the evaluation unit signaling an incorrect operating state, measures are initiated or method steps are carried out that lead to correct pressure conditions.
  • the pressure-based control device generates a release signal for the control unit, the control unit being configured such that the valve device is only activated in such a way that the valve device assumes the first operating position when the control unit receives a control signal for setting the special operating mode and receives the release signal. Consequently, the flow connection can only be established by means of the valve device if it is ensured that the liquid cannot get into the part of the liquid system in which the fresh treatment liquid is located.
  • the first flow path comprises a first filter which is divided into a first filter chamber and a second filter chamber by a semipermeable membrane.
  • This filter can serve as a sterile filter for the fresh dialysis fluid.
  • An upstream section of the first flow path connects the liquid source to the first filter chamber of the filter and a downstream section of the first flow path connects the second filter chamber of the filter to an inlet of the first compartment of the blood treatment unit.
  • the upstream portion of the flow path for the particular mode of operation may be a conduit portion that is in fluid communication with the downstream portion of the first flow path.
  • downstream section of the flow path is in flow connection with the second flow path and thus with the outlet for a particular operating mode, For the special operating state downstream of the sterile filter, a flow connection can be created between the first flow path for fresh treatment liquid and the second flow path for used treatment liquid, bypassing the blood treatment unit (bypass).
  • the first pressure gauge can be arranged on the downstream part of the first flow path, and the second pressure gauge can be arranged on the second flow path.
  • An arrangement of the pressure gauges not directly on the upstream and downstream sections of the flow path for a particular operating mode can be useful if pressure gauges are already provided on other fluid lines in the blood treatment device for monitoring the pressure.
  • the extracorporeal blood circuit comprises a venous blood line and an arterial blood line
  • the upstream section of the flow path for a particular operating mode is a line section of the venous blood line or a line section in fluid communication with the venous blood line.
  • the monitoring of the direction of flow allows only a flow of liquid from the venous blood line into the outlet.
  • the first pressure meter can be arranged on the venous blood line and the second pressure meter can be arranged on the second flow path.
  • the method according to the invention for operating an extracorporeal blood treatment device provides that before a flow connection is established between an upstream section of a flow path for a particular operating state and a downstream section of the flow path which is in flow connection with the second flow path for a particular operating state, the upstream pressure in the upstream Section and the downstream Wärtige pressure in the downstream section of the flow path is measured for a particular operating condition.
  • the flow communication between the upstream and downstream sections of the A flow path for a particular operating condition is only established when the upstream pressure is higher than the downstream pressure.
  • Fig. 1 shows an embodiment of the invention
  • Blood treatment device in a greatly simplified schematic representation, the direction of flow of a liquid being monitored for the control of a first valve device, and
  • Fig. 2 shows an embodiment of the invention
  • Blood treatment device in a greatly simplified schematic representation, the direction of flow of a liquid being monitored for the control of a second valve device.
  • the blood treatment device in particular a hemo (dia) filtration device, is equipped for operation with a blood treatment unit 1, in particular a dialyzer, which is passed through a semipermeable membrane 2 into a first compartment 3, in particular a dialysis fluid chamber, and a second compartment 4, in particular a blood chamber , is divided.
  • a blood supply line 5 into which a blood pump leads leads to the inlet 4a of the blood chamber 4
  • the fluid system II of the blood treatment device is described below. Blood supply and discharge lines 5, 7 are part of a hose system that is connected to the blood treatment device.
  • the fluid system II of the blood treatment device in particular the dialysis fluid system, has a dialysis fluid supply line 8, which leads from a dialysis fluid source 9 to an inlet 3a of the dialysis fluid chamber 3, and a dialysis fluid discharge line 10, which branches off from an outlet 3b of the dialysis fluid chamber 3 and leads to an outlet 11 .
  • the dialysis fluid supply line 8 has a first section 8A which leads from the dialysis fluid source 9 to the first filter chamber 12A of a first sterile filter 12 which is divided by a semipermeable membrane 12C into the first filter chamber 12A and a second filter chamber 12B.
  • One chamber 13 A of a balancing device 13 is connected to the first section 8A of the dialysis fluid supply line 8.
  • the hemo (dia) filtration device can have a second sterile filter 14, which is divided into a first filter chamber 16 and a second filter chamber 17 by a semipermeable membrane 15.
  • the first filter chamber 16 of the second sterile filter 14 is connected to the second section 8B of the dialysis fluid supply line 8.
  • the substituate line is not shown in FIG. 1.
  • the dialysis fluid discharge line 10 is divided into two sections 10A and 10B, which lead to the drain 11.
  • a dialysis fluid pump 18 is connected in the first section 10A, while an ultrafiltrate pump 19 is connected in the second section 10B.
  • the other chamber 13B of the balancing device 13 is connected to the second section 10B.
  • the dialysis fluid supply line represents a first flow path 8 in which fresh dialysis fluid from the dialysis fluid source 9 to the Dialysis fluid chamber 3 flows
  • the dialysis fluid discharge line represents a second flow path 10 in which used dialysis fluid flows from dialysis fluid chamber 3 to drain 11.
  • the flow paths form all sections of the relevant lines, including the components connected into the lines.
  • a first valve device 21 is connected, which has an electromagnetically actuated shut-off device 21A.
  • the bypass line represents a flow path 20 which is provided for a special operating mode.
  • This operating mode can, for example, be a malfunction, for example the detection of an incorrect composition of the dialysis fluid, which can be detected with a conductivity measurement.
  • the shut-off element 21 A of the first valve device 21 is opened so that the dialysis fluid can be conducted into the outlet 11 by bypassing the dialyzer 3.
  • a shut-off element 22 is provided upstream and a shut-off element 23 is provided downstream of the dialysis fluid chamber 3.
  • the line section of the bypass line 20 connected to the dialysis fluid supply line 8 is referred to below as the upstream section 20A and the line section of the bypass line 20 connected to the dialysis fluid discharge line 10 as the downstream section of the flow path 20 for a particular operating mode.
  • the second filter chamber of the second sterile filter 14 is connected to the dialysis fluid discharge line 10 via a connecting line 24.
  • a second valve device 25 which has an electromagnetically actuatable shut-off element 25A, is connected into the connecting line 10. Upstream of this shut-off device 25A there is a connection piece 26 (port) to which the venous blood line 7A (FIG. 2) can be connected in order to flush the venous blood line 7A.
  • shut-off devices or connection pieces can be provided, but these are not important for an understanding of the invention, for example the line 28 and the shut-off devices 29, 30 or the connection piece 35 (port).
  • the blood treatment apparatus has a control unit 31 which is configured in such a way that the shut-off element 21A or 25A of the first and second valve devices 21, 25 can be opened or closed.
  • control unit 31 can also control the other shut-off devices.
  • the blood treatment device has a control device 32 which has an evaluation unit 32A which receives the measurement signal from a first pressure gauge 33 and the measurement signal from a second pressure gauge 34.
  • the first pressure meter 33 is arranged on the downstream section 8B of the dialysis fluid supply line 8 and measures the pressure Pi in this line section, while the second pressure meter 34 is arranged upstream of the dialysis fluid pump 18 and the ultrafiltrate pump 19 on the dialysis fluid discharge line 10 and measures the pressure P2 in this line section.
  • the two pressure gauges 33, 34 are connected to the control device 32 via signal lines 33, 34 ‘.
  • the first and second shut-off devices 21A, 25B are closed. If a particular operating mode is specified, the control unit 31 receives a control signal in order to open the first or second shut-off element 21A, 25B. In the present exemplary embodiment, it is assumed that the control unit 31 sends a control signal to open the first or second blocking element from a central control and computing unit (not shown) of the blood treatment device, which controls the preparation of the blood treatment device for the blood treatment and the blood treatment.
  • the evaluation unit 32A forms the difference between the pressure Pi measured with the first pressure gauge 33 and the pressure P2 measured with the second pressure gauge 34 and generates a release signal which the control unit 31 receives when the difference is greater than 0, i.e. H. Pi> P2.
  • the control unit 31 opens the first or second blocking element 21 A or 25 A only when it receives both the corresponding control signal for the first or second blocking element from the central control and computing unit and the release signal from the evaluation unit 32A.
  • FIG. 2 shows the extracorporeal blood treatment device from FIG.
  • the venous hose line 7A being connected to the connection piece 26 for preparing the blood treatment, so that a rinsing liquid can flow through the venous blood line 7A to the outlet 11 when the shut-off device 25A of the second Valve device 25 is open.
  • the shut-off element 27 is closed upstream of the shut-off element 25A of the second valve device 25.
  • the first pressure gauge is a pressure gauge 33 (FIG. 2) which is arranged on the venous blood line 7A and which measures the pressure Pi in this line upstream of the shut-off device 25A of the second valve device 25.
  • the second pressure gauge is one on the other
  • Dialysis fluid discharge line 10 arranged pressure gauge 34, which measures the pressure P2 in this line.
  • the shut-off element 25A of the second valve device 25 is only opened when the pressure Pi> P2, so that it is ensured that flushing liquid can only flow in the direction of the second flow path 10.
  • the direction of flow for the rinsing liquid is indicated by arrows when the shut-off element 25A of the second valve device 25 is open.

Landscapes

  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Urology & Nephrology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Emergency Medicine (AREA)
  • Cardiology (AREA)
  • External Artificial Organs (AREA)

Abstract

L'invention concerne un dispositif de traitement de sang extracorporel qui comprend une unité de traitement de sang 1 qui est subdivisée par une membrane semi-perméable 2 en un premier compartiment 3 qui constitue une partie d'un système fluidique II et un second compartiment 4 qui constitue une partie d'un circuit de sang extracorporel I. L'invention concerne en outre un procédé pour faire fonctionner un tel dispositif de traitement de sang. Le dispositif de traitement de sang selon l'invention dispose d'un dispositif de commande 32 dont le fonctionnement repose sur la pression, qui coopère avec l'unité de commande 31 pour un dispositif de clapet 21 et qui est conçu de telle sorte qu'une liaison fluidique entre une section amont 20A et une section aval 20B d'une voie de circulation 20 ne peut être établie pour un mode de fonctionnement particulier uniquement lorsque le dispositif de commande 32 dont le fonctionnement repose sur la pression constate un état de fonctionnement dans lequel il est garanti que du liquide circule dans la voie de circulation 20 pour un mode de fonctionnement particulier, en direction d'une voie de circulation 10 menant à une sortie 11. Cela permet de garantir que le liquide concerné ne peut circuler que dans la voie de circulation 10 qui mène à la sortie 11, mais ne peut pas se retrouver dans une autre voie de circulation 8 dans laquelle se trouve du liquide de traitement frais.
EP21721430.3A 2020-04-30 2021-04-21 Dispositif de traitement de sang extracorporel Pending EP4142823A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102020111764.7A DE102020111764A1 (de) 2020-04-30 2020-04-30 Extrakorporale Blutbehandlungsvorrichtung und Verfahren zum Betreiben einer extrakorporalen Blutbehandlungsvorrichtung
PCT/EP2021/060316 WO2021219451A1 (fr) 2020-04-30 2021-04-21 Dispositif de traitement de sang extracorporel

Publications (1)

Publication Number Publication Date
EP4142823A1 true EP4142823A1 (fr) 2023-03-08

Family

ID=75674792

Family Applications (1)

Application Number Title Priority Date Filing Date
EP21721430.3A Pending EP4142823A1 (fr) 2020-04-30 2021-04-21 Dispositif de traitement de sang extracorporel

Country Status (8)

Country Link
US (1) US20230158217A1 (fr)
EP (1) EP4142823A1 (fr)
JP (1) JP2023523467A (fr)
CN (1) CN115461099A (fr)
AU (1) AU2021262429A1 (fr)
CA (1) CA3175697A1 (fr)
DE (1) DE102020111764A1 (fr)
WO (1) WO2021219451A1 (fr)

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102010032154A1 (de) 2010-07-23 2012-01-26 Fresenius Medical Care Deutschland Gmbh Vorrichtung und Verfahren zur Überwachung des Anschlusses einer Blutbehandlungseinheit an das Flüssigkeitssystem einer extrakorporalen Blutbehandlungsvorrichtung
DE102012008551B4 (de) 2012-04-30 2017-09-07 Fresenius Medical Care Deutschland Gmbh Vorrichtung zur Durchführung eines Verfahrens zur Konservierung einer Blutbehandlungsvorrichtung sowie Verfahren zur Konservierung einer Blutbehandlungsvorrichtung
DE102016004908A1 (de) 2016-04-22 2017-10-26 Fresenius Medical Care Deutschland Gmbh Medizinische Behandlungsvorrichtung und Verfahren zur Überwachung einer medizinische Behandlungsvorrichtung

Also Published As

Publication number Publication date
DE102020111764A1 (de) 2021-11-04
CN115461099A (zh) 2022-12-09
CA3175697A1 (fr) 2021-11-04
AU2021262429A1 (en) 2022-11-17
JP2023523467A (ja) 2023-06-05
US20230158217A1 (en) 2023-05-25
WO2021219451A1 (fr) 2021-11-04

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