WO2004045678A1 - Haemodialysis unit - Google Patents

Haemodialysis unit Download PDF

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Publication number
WO2004045678A1
WO2004045678A1 PCT/DE2003/003523 DE0303523W WO2004045678A1 WO 2004045678 A1 WO2004045678 A1 WO 2004045678A1 DE 0303523 W DE0303523 W DE 0303523W WO 2004045678 A1 WO2004045678 A1 WO 2004045678A1
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WIPO (PCT)
Prior art keywords
chamber
sterile filter
dialysis fluid
outlet
dialyzer
Prior art date
Application number
PCT/DE2003/003523
Other languages
German (de)
French (fr)
Inventor
Roland Seifert
Original Assignee
Mesys 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.)
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Publication date
Application filed by Mesys Gmbh filed Critical Mesys Gmbh
Priority to AU2003281964A priority Critical patent/AU2003281964A1/en
Publication of WO2004045678A1 publication Critical patent/WO2004045678A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/1654Dialysates therefor
    • A61M1/1656Apparatus for preparing dialysates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/1654Dialysates therefor
    • A61M1/1656Apparatus for preparing dialysates
    • A61M1/1668Details of containers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/75General characteristics of the apparatus with filters
    • A61M2205/7518General characteristics of the apparatus with filters bacterial
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/75General characteristics of the apparatus with filters
    • A61M2205/7563General characteristics of the apparatus with filters with means preventing clogging of filters

Definitions

  • the invention relates to a hemodialysis machine with a dialyzer connected between a dialysis fluid path and a blood path and with a sterile filter in the dialysis fluid path, the sterile filter being divided by a membrane into a first chamber and a second chamber, and an inlet of the first chamber to a dialysis fluid.
  • Supply line and the second chamber is connected to the dialyzer, and wherein a shut-off valve is provided in the dialysis fluid path between the second chamber of the sterile filter and the dialyzer.
  • Hemodialysis machines are used to remove metabolic products and, if necessary, water from a patient's blood, particularly in the case of renal failure of the patient.
  • a dialyzer is used, which is divided into two chambers with a membrane.
  • a dialysis fluid is passed on one side of the membrane and the patient's blood on the other side.
  • the dialysis fluid absorbs the metabolic products that are to be removed from the blood through the pores of the membrane.
  • water can also be removed from the blood using ultrafiltration.
  • the dialysis fluid is made from fresh water and a self-sterile electrolyte concentrate.
  • the dialysis fluid path is in front of the dialyzer.
  • a sterile filter is connected, which generally extends in a cylindrical shape and is divided into an inner first chamber and an outer second chamber by radially arranged membranes extending in the longitudinal direction.
  • a connection is provided for each chamber at the two opposite ends of the sterile filter for each chamber.
  • the two connections of the second chamber of the sterile filter are connected to the inlet of the dialyzer.
  • a hemodialysis machine is known from JP 56-158664, in which the outlet of the first chamber of the sterile filter is connected to a drain for the dialysis liquid via a servo valve and an optional throttle.
  • the dialyzing process can be interrupted and the dialyzing liquid can be completely passed through the first chamber of the sterile filter by opening the servo valve. This flushes and cleans the sterile filter. If the outlet of the first chamber is closed during operation, particles and other substances can accumulate over time, in particular in the area of the closed end of the sterile filter, and clog the sterile filter.
  • a disadvantage is that an unintentional opening of the servo valve during the treatment leads to a drop in pressure in the dialyzer.
  • EP 0 270 794 B1 describes a hemodialysis machine in which the outlet of the first chamber of the sterile filter is connected to the discharge line of the dialyzer with a bypass line and a bypass valve in the bypass line. Each time the hemodialysis machine is disinfected and rinsed, the dialyzer is disconnected with a shut-off valve and the bypass line is opened. Then the sterile filter is rinsed automatically.
  • the object of the invention was to provide an improved hemodialysis machine with a safe and inexpensive way of rinsing the sterile filter.
  • the object is achieved by the generic hemodialysis machine according to the invention in that an outlet of the first chamber of the sterile filter is connected to a drain for the dialysis fluid with a check valve.
  • the sterile filter is flushed only if the pressure for the check valve is sufficiently high. This is the case when the dialyzer is disconnected using shut-off valves and the dialysis fluid continues to be pumped through the sterile filter.
  • control of the rinsing process is pressure-dependent and can be implemented safely and easily without further actuation elements.
  • the inlet of the first chamber of the sterile filter and the outlet of the first chamber are preferably arranged at a distance from one another such that the inlet is in the region of a first end of the sterile filter and the outlet is in the region of a second end of the sterile filter.
  • a shut-off valve is preferably provided in the dialysis fluid path between the second chamber of the sterile filter and the dialyzer and between the outlet of the dialyzer and a drain line for dialysis fluid.
  • a bypass line with a bypass valve is provided between the inlet of the first chamber of the sterile filter and the outlet line for the dialysis fluid.
  • the dialysis fluid can also be drained without passing through the sterile filter and flushing it.
  • the pressure conditions can also be set before the sterile filter.
  • conventional bypass lines are located behind the sterile filter, as seen in the flow direction of the dialysis liquid, that is to say at the outlet of the first chamber and not, as now proposed, at the inlet.
  • FIG. 1 - block diagram of a section of a hemodialysis device according to the invention with sterile filter and check valve.
  • FIG. 1 shows a section of a hemodialysis machine as a block diagram.
  • the hemodialysis machine has a dialysis fluid circuit with a dialysis fluid supply line 1 and a drain line 2 for the dialysis fluid and a blood path 3.
  • the dialysis fluid circuit and the blood path 3 are separated from one another by a dialyzer 4, which is separated by a membrane 5 in a known manner a first chamber for dialysis fluid and a second chamber for the blood flowing through a patient is divided.
  • a sterile filter 6 is connected into the dialysis fluid supply line 1 of the dialysis fluid path.
  • the sterile filter 6 is divided by a membrane 7 into a first chamber 8 and a second chamber 9.
  • the dialysis fluid supply line 1 is connected to an inlet 10 of the first chamber 8 of the sterile filter 6.
  • the second chamber 9 of the sterile filter each has an outlet 11, 12 at that end of the sterile filter 6, the outlets of the second chamber 9 of the sterile filter 6 being connected to the dialysing liquid inlet of the dialyzer 4 via a flow shut-off valve 13.
  • the dialysis fluid outlet of the dialyzer 4 is connected to the drain line 2 for the dialysis fluid via a non-return valve 14.
  • the flow shut-off valve 13 and the return shut-off valve 14 are open and the dialysis fluid flows through the dialysis fluid supply line 1, the sterile filter 6 and the dialyzer 4 and is disposed of via the drain line 2.
  • the first chamber 8 of the sterile filter 6 has an outlet 15 at the end opposite the inlet 10 of the first chamber 8, which outlet is usually closed during operation. Because of this dead end, particles and other substances, such as e.g. Pyrogens, accumulate from membrane 7 and block it.
  • the outlet 15 of the first chamber 8 is connected to an outlet 17 for the dialysis fluid via a check valve 16.
  • the drain 17 can open into the drain pipe 2, for example.
  • the inlet 10 of the first chamber 8 of the sterile filter 6 is connected to the drain line 2 via a bypass line 18 and a bypass valve 19 connected to the bypass line 18, so that the sterile filter 6 and the dialyzer 4 can be short-circuited.
  • the bypass valve 19, the flow shut-off valve 13 and the return shut-off valve 14 are closed at the same time. This leads to an increase in pressure in the dialysis fluid path, which is determined by the opening pressure of the check valve 16, provided that the dialysate flow rate is kept constant with the aid of a flow control. After the check valve 16 is opened, residual air from the dialysis fluid path and impurities enter the outlet 17.
  • the check valve 16 also has the advantage that an excessive system pressure is prevented in the event of a technical fault.
  • the sterile filter 6 is protected against an impermissible pressure load.
  • the check valve 16 prevents liquid from getting into the hydraulic system from the outlet 17.
  • venting or rinsing process is automatically carried out cyclically during the treatment.
  • the sterile filter 6 can also be vented and flushed by cyclically closing the bypass valve 19 and the flow and return valves 13, 14.
  • dialysate flow can be led directly from the inlet 10 of the sterile filter 6 into the outlet line 2 by opening the bypass valve 19 via the bypass line 18, without this flowing into the sterile filter 6 and the safety-critical branch of the dialysis fluid between the second chamber 9 of the sterile filter 6 and the dialyzer 4.

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

Abstract

The invention relates to a haemodialysis unit with a dialyser (4), arranged between a dialysis fluid circulation and a blood circulation (3) and a sterile filter in the dialysis fluid circulation, whereby the sterile filter (6) is divided by a membrane (7) into a first chamber (8) and a second chamber (9). An inlet (10) to the first chamber (8) is connected to a dialysis fluid supply (1) and the second chamber (9) is connected to the dialyser (4). An outlet (15) from the first chamber (8) of the sterile filter (6) is connected by means of a non-return valve (16) to an outlet (17) for the dialysis fluid.

Description

Hämodialysegeräthemodialysis
Die Erfindung betrifft ein Hämodialysegerät mit einem zwischen einem Dialysierflussigkeitsweg und einem Blutweg geschalteten Dialysator und mit einem Sterilfilter in dem Dialysierflussigkeitsweg, wobei das Sterilfilter durch eine Membran in eine erste Kammer und eine zweite Kammer geteilt ist, und ein Einlass der ersten Kammer an eine Dialysierflüssigkeits- Zuleitung und die zweite Kammer an den Dialysator angeschlossen ist, und wobei in dem Dialysierflussigkeitsweg zwischen der zweiten Kammer des Sterilfilters und dem Dialysator ein Absperrventil vorgesehen ist.The invention relates to a hemodialysis machine with a dialyzer connected between a dialysis fluid path and a blood path and with a sterile filter in the dialysis fluid path, the sterile filter being divided by a membrane into a first chamber and a second chamber, and an inlet of the first chamber to a dialysis fluid. Supply line and the second chamber is connected to the dialyzer, and wherein a shut-off valve is provided in the dialysis fluid path between the second chamber of the sterile filter and the dialyzer.
Hämodialysegeräte werden zum Entfernen von Stoffwechselprodukten und ggf. von Wasser aus dem Blut eines Patienten, insbesondere bei Niereninsuffizienz des Patienten, eingesetzt. Hierzu wird ein Dialysator eingesetzt, der mit einer Membran in zwei Kammern aufgeteilt ist. Auf der einen Seite der Membran wird eine Dialysierflüssigkeit vorbeigeführt und auf der anderen Seite das Blut des Patienten. Die Dialysierflüssigkeit nimmt durch die Poren der Membrane hindurch die Stoffwechselprodukte auf, die aus dem Blut zu entfernen sind. Mit Hilfe eines Unterdrucks an der Membran kann zusätzlich Wasser mittels Ultrafiltration aus dem Blut entfernt werden.Hemodialysis machines are used to remove metabolic products and, if necessary, water from a patient's blood, particularly in the case of renal failure of the patient. For this purpose, a dialyzer is used, which is divided into two chambers with a membrane. A dialysis fluid is passed on one side of the membrane and the patient's blood on the other side. The dialysis fluid absorbs the metabolic products that are to be removed from the blood through the pores of the membrane. With the help of a vacuum on the membrane, water can also be removed from the blood using ultrafiltration.
Die Dialysierflüssigkeit wird aus Frischwasser und einem eigensterilen Elektrolytkonzentrat hergestellt. Um eine absolut sterile Dialysierflüssigkeit zu gewähr-leisten, wird in den Dialysierflussigkeitsweg vor den Dialysator her- kömmlicherweise ein Sterilfilter geschaltet, das sich in der Regel zylinder- förmig erstreckt und durch radial angeordnete sich in Längsrichtung erstreckende Membrane in eine innere erste Kammer und eine äußere zweite Kammer geteilt ist. Für jede Kammer ist an den beiden gegenüberliegenden Enden des Sterilfilters ist für jede Kammer jeweils ein Anschluss vorgesehen. Die beiden Anschlüsse der zweiten Kammer des Sterilfilters sind an den Einlass des Dialysators geschaltet.The dialysis fluid is made from fresh water and a self-sterile electrolyte concentrate. In order to guarantee an absolutely sterile dialysis fluid, the dialysis fluid path is in front of the dialyzer. Conventionally, a sterile filter is connected, which generally extends in a cylindrical shape and is divided into an inner first chamber and an outer second chamber by radially arranged membranes extending in the longitudinal direction. A connection is provided for each chamber at the two opposite ends of the sterile filter for each chamber. The two connections of the second chamber of the sterile filter are connected to the inlet of the dialyzer.
Aus der JP 56-158664 ist ein Hämodialysegerät bekannt, bei der der Aus- lass der ersten Kammer des Sterilfilters über ein Servoventil und eine optionale Drossel mit einem Ablauf für die Dialysierflüssigkeit verbunden ist. Mit Hilfe eines Absperrventils zwischen dem Auslass der zweiten Kammer und dem Dialysator kann der Dialysiervorgang unterbrochen werden und durch Öffnen des Servoventils die Dialysierflüssigkeit vollständig durch die erste Kammer des Sterilfilters geleitet werden. Hierdurch wird der Sterilfilter durchspült und gereinigt. Wenn der Auslass der ersten Kammer nämlich während des Betriebs geschlossen ist, können sich im Laufe der Zeit Partikel und andere Substanzen insbesondere im Bereich des verschlossenen Endes des Sterilfilters ansammeln und den Sterilfilter verstopfen. Nachteilig führt ein unbeabsichtigtes Öffnen des Servoventils während der Behandlung zu einem Druckabfall in dem Dialysator.A hemodialysis machine is known from JP 56-158664, in which the outlet of the first chamber of the sterile filter is connected to a drain for the dialysis liquid via a servo valve and an optional throttle. With the help of a shut-off valve between the outlet of the second chamber and the dialyzer, the dialyzing process can be interrupted and the dialyzing liquid can be completely passed through the first chamber of the sterile filter by opening the servo valve. This flushes and cleans the sterile filter. If the outlet of the first chamber is closed during operation, particles and other substances can accumulate over time, in particular in the area of the closed end of the sterile filter, and clog the sterile filter. A disadvantage is that an unintentional opening of the servo valve during the treatment leads to a drop in pressure in the dialyzer.
In der EP 0 270 794 B1 ist ein Hämodialysegerät beschrieben, bei dem der Auslass der ersten Kammer des Sterilfilters mit einer Bypassleitung und ei- nem Bypassventil in der Bypassleitung an die Ableitung des Dialysators geschaltet ist. Bei jedem Desinfektions- und Spülvorgang des Hämodialysege- räts wird der Dialysator mit einem Absperrventil abgeklemmt und die Bypassleitung geöffnet. Dann wird das Sterilfilter automatisch gespült. Aufgabe der Erfindung war es, ein verbessertes Hämodialysegerät mit einer sicheren und kostengünstigen Möglichkeit zum Spülen des Sterilfilters zu schaffen.EP 0 270 794 B1 describes a hemodialysis machine in which the outlet of the first chamber of the sterile filter is connected to the discharge line of the dialyzer with a bypass line and a bypass valve in the bypass line. Each time the hemodialysis machine is disinfected and rinsed, the dialyzer is disconnected with a shut-off valve and the bypass line is opened. Then the sterile filter is rinsed automatically. The object of the invention was to provide an improved hemodialysis machine with a safe and inexpensive way of rinsing the sterile filter.
Die Aufgabe wird durch das gattungsgemäße Hämodialysegrät erfindungsgemäß dadurch gelöst, dass ein Auslass der ersten Kammer des Sterilfilters mit einem Rückschlagventil an einen Ablauf für die Dialysierflüssigkeit angeschlossen ist.The object is achieved by the generic hemodialysis machine according to the invention in that an outlet of the first chamber of the sterile filter is connected to a drain for the dialysis fluid with a check valve.
Durch die Verwendung eines Rückschlagventils erfolgt eine Spülung des Sterilfilters nur dann, wenn der Druck für das Rückschlagventil ausreichend groß ist. Dies ist genau dann gegeben, wenn der Dialysator mit Hilfe von Absperrventilen abgeklemmt ist und die Dialysierflüssigkeit weiterhin durch den Sterilfilter gepumpt wird.By using a check valve, the sterile filter is flushed only if the pressure for the check valve is sufficiently high. This is the case when the dialyzer is disconnected using shut-off valves and the dialysis fluid continues to be pumped through the sterile filter.
Erfindungsgemäß erfolgt somit die Steuerung des Spülvorgangs druckabhängig und kann ohne weitere Betätigungselemente sicher und einfach realisiert werden.According to the invention, the control of the rinsing process is pressure-dependent and can be implemented safely and easily without further actuation elements.
Der Einlass der ersten Kammer des Sterilfilters und der Auslass der ersten Kammer sind vorzugsweise entfernt voneinander so angeordnet, dass der Einlass im Bereich eines ersten Endes des Sterilfilters und der Auslass im Bereich eines zweiten Endes des Sterilfilters liegt.The inlet of the first chamber of the sterile filter and the outlet of the first chamber are preferably arranged at a distance from one another such that the inlet is in the region of a first end of the sterile filter and the outlet is in the region of a second end of the sterile filter.
In dem Dialysierflussigkeitsweg ist vorzugsweise zwischen der zweiten Kammer des Sterilfilters und dem Dialysator sowie zwischen dem Auslass des Dialysators und einer Ablaufleitung für Dialysierflüssigkeit jeweils ein Absperrventil vorgesehen. Durch Schließen der Absperrventile wird der Behandlungsvorgang beendet und die Dialysierflüssigkeit wird dann über das sich selbsttätig öffnende Rücksperrventil durch die erste Kammer des Sterilfilters in einen Ablauf geleitet. Auf diese Weise wird das Sterilfilter automatisch gespült.A shut-off valve is preferably provided in the dialysis fluid path between the second chamber of the sterile filter and the dialyzer and between the outlet of the dialyzer and a drain line for dialysis fluid. By closing the shut-off valves, the treatment process is ended and the dialysis fluid is then over the automatically opening check valve is led through the first chamber of the sterile filter into a drain. In this way, the sterile filter is rinsed automatically.
In einer vorteilhaften Ausführungsform des Hämodialysegerätes ist eine Bypassleitung mit einem Bypassventil zwischen dem Einlass der ersten Kammer des Sterilfilters und der Ablaufleitung für die Dialysierflüssigkeit vorgesehen. Damit kann die Dialysierflüssigkeit auch abgeleitet werden, ohne das sie das Sterilfilter passiert und dieses gespült wird. Mit der Bypassleitung können auch die Druckverhältnisse bereits vor dem Sterilfilter eingestellt werden. Im Unterschied hierzu befinden sich herkömmliche Bypassleitungen in Strömungsrichtung der Dialysierflüssigkeit gesehen hinter dem Sterilfilter, das heißt am Auslass der ersten Kammer und nicht wie nunmehr vorgeschlagen am Einlass. In an advantageous embodiment of the hemodialysis machine, a bypass line with a bypass valve is provided between the inlet of the first chamber of the sterile filter and the outlet line for the dialysis fluid. This means that the dialysis fluid can also be drained without passing through the sterile filter and flushing it. With the bypass line, the pressure conditions can also be set before the sterile filter. In contrast to this, conventional bypass lines are located behind the sterile filter, as seen in the flow direction of the dialysis liquid, that is to say at the outlet of the first chamber and not, as now proposed, at the inlet.
Die Erfindung wird nachfolgend anhand der beigefügten Zeichnung näher erläutert. Es zeigt:The invention is explained in more detail below with reference to the accompanying drawing. It shows:
Figur 1 - Blockdiagramm eines Ausschnitts eines erfindungsgemäßen Hämodialysegeräts mit Sterilfilter und Rückschlagventil.Figure 1 - block diagram of a section of a hemodialysis device according to the invention with sterile filter and check valve.
Die Figur 1 lässt einen Ausschnitt eines Hämodialysegerätes als Blockdiagramm erkennen. Das Hämodialysegerät hat einen Dialysierflüssigkeits- kreislauf mit einer Dialysefüssigkeits-Zuleitung 1 und einer Ablaufleitung 2 für die Dialysierflüssigkeit sowie einen Blutweg 3. Der Dialysierflüssigkeits- kreislauf und der Blutweg 3 sind mit einem Dialysator 4 voneinander getrennt, der durch eine Membran 5 in bekannter Weise in eine erste Kammer für Dialysierflüssigkeit und eine zweite Kammer für das durchströmende Blut eines Patienten aufgeteilt ist.FIG. 1 shows a section of a hemodialysis machine as a block diagram. The hemodialysis machine has a dialysis fluid circuit with a dialysis fluid supply line 1 and a drain line 2 for the dialysis fluid and a blood path 3. The dialysis fluid circuit and the blood path 3 are separated from one another by a dialyzer 4, which is separated by a membrane 5 in a known manner a first chamber for dialysis fluid and a second chamber for the blood flowing through a patient is divided.
Um zu gewährleisten, dass die Dialysierflüssigkeit steril ist, ist in die Dialy- sierflüssigkeits-Zuleitung 1 des Dialysierflüssigkeitsweges ein Sterilfilter 6 geschaltet. Das Sterilfilter 6 ist durch eine Membran 7 in eine erste Kammer 8 und eine zweite Kammer 9 aufgeteilt. Die Dialysierflüssigkeits-Zuleitung 1 ist an einen Einlass 10 der ersten Kammer 8 des Sterilfilters 6 angeschlossen.In order to ensure that the dialysis fluid is sterile, a sterile filter 6 is connected into the dialysis fluid supply line 1 of the dialysis fluid path. The sterile filter 6 is divided by a membrane 7 into a first chamber 8 and a second chamber 9. The dialysis fluid supply line 1 is connected to an inlet 10 of the first chamber 8 of the sterile filter 6.
Die zweite Kammer 9 des Sterilfilters hat jeweils einen Auslass 1 1 , 12 an jenem Ende des Sterilfilters 6, wobei die Auslässe der zweiten Kammer 9 des Sterilfilters 6 über ein Vorlauf-Absperrventil 13 mit dem Dialysierflüs- sigkeits-Einlass des Dialysators 4 verbunden ist. Der Dialysierflüssigkeits- Auslass des Dialysators 4 ist über ein Rücklauf-Absperrventil 14 mit der Ablaufleitung 2 für die Dialysierflüssigkeit verbunden. Während der Behandlung eines Patienten ist das Vorlauf-Absperrventil 13 und das Rücklauf-Absperrventil 14 geöffnet und die Dialysierflüssigkeit strömt durch die Dialysierflüssigkeits-Zuleitung 1 , das Sterilfilter 6 und den Dialysator 4 und wird über die Ablaufleitung 2 entsorgt.The second chamber 9 of the sterile filter each has an outlet 11, 12 at that end of the sterile filter 6, the outlets of the second chamber 9 of the sterile filter 6 being connected to the dialysing liquid inlet of the dialyzer 4 via a flow shut-off valve 13. The dialysis fluid outlet of the dialyzer 4 is connected to the drain line 2 for the dialysis fluid via a non-return valve 14. During the treatment of a patient, the flow shut-off valve 13 and the return shut-off valve 14 are open and the dialysis fluid flows through the dialysis fluid supply line 1, the sterile filter 6 and the dialyzer 4 and is disposed of via the drain line 2.
Die erste Kammer 8 des Sterilfilters 6 hat an dem Ende, das dem Einlass 10 der ersten Kammer 8 gegenüberliegt, einen Auslass 15, der im Betrieb üblicherweise verschlossen ist. Aufgrund dieses toten Endes können sich besonders in dem Bereich des Auslasses 15 der ersten Kammer 8 Partikel und andere Substanzen, wie z.B. Pyrogene, von der Membran 7 ansammeln und diese verstopfen.The first chamber 8 of the sterile filter 6 has an outlet 15 at the end opposite the inlet 10 of the first chamber 8, which outlet is usually closed during operation. Because of this dead end, particles and other substances, such as e.g. Pyrogens, accumulate from membrane 7 and block it.
Erfindungsgemäß ist der Auslass 15 der ersten Kammer 8 über ein Rückschlagventil 16 mit einem Ablauf 17 für die Dialysierflüssigkeit verbunden. Der Ablauf 17 kann beispielsweise in die Ablaufleitung 2 münden.According to the invention, the outlet 15 of the first chamber 8 is connected to an outlet 17 for the dialysis fluid via a check valve 16. The drain 17 can open into the drain pipe 2, for example.
Zudem ist der Einlass 10 der ersten Kammer 8 des Sterilfilters 6 über eine Bypassleitung 18 und ein in die Bypassleitung 18 geschaltetes Bypassventil 19 mit der Ablaufleitung 2 verbunden, so dass das Sterilfilter 6 und der Dialysator 4 kurzgeschlossen werden können.In addition, the inlet 10 of the first chamber 8 of the sterile filter 6 is connected to the drain line 2 via a bypass line 18 and a bypass valve 19 connected to the bypass line 18, so that the sterile filter 6 and the dialyzer 4 can be short-circuited.
Zum Entlüften und/oder Spülen des Sterilfilters werden das Bypassventil 19, das Vorlauf-Absperrventil 13 und das Rücklauf-Absperrventil 14 gleichzeitig geschlossen. Dabei kommt es zu einem Druckanstieg in dem Dialy- sierflüssigkeitsweg, der durch den Öffnungsdruck des Rückschlagventils 16 bestimmt ist, sofern die Dialysatflussrate mit Hilfe einer Flussregelung konstant gehalten wird. Nach Öffnen des Rückschlagventils 16 gelangt restliche Luft aus dem Dialysierflussigkeitsweg sowie Verunreinigungen in den Ablauf 17.To vent and / or flush the sterile filter, the bypass valve 19, the flow shut-off valve 13 and the return shut-off valve 14 are closed at the same time. This leads to an increase in pressure in the dialysis fluid path, which is determined by the opening pressure of the check valve 16, provided that the dialysate flow rate is kept constant with the aid of a flow control. After the check valve 16 is opened, residual air from the dialysis fluid path and impurities enter the outlet 17.
Das Rückschlagventil 16 hat weiterhin den Vorteil, dass ein zu hoher Systemdruck im Falle eines technischen Fehlers verhindert wird. Zudem wird das Sterilfilter 6 vor einer unzulässigen Druckbelastung geschützt. Weiterhin wird durch das Rückschlagventil 16 verhindert, dass Flüssigkeit von dem Ablauf 17 in das hydraulische System gelangen kann.The check valve 16 also has the advantage that an excessive system pressure is prevented in the event of a technical fault. In addition, the sterile filter 6 is protected against an impermissible pressure load. Furthermore, the check valve 16 prevents liquid from getting into the hydraulic system from the outlet 17.
Der beschriebene Entlüftungs- bzw. Spülvorgang wird während der Behandlung automatisch zyklisch durchgeführt. Bei der Desinfektion des Hämodialysegerätes kann zudem eine Entlüftung und Spülung des Sterilfilters 6 durch zyklisches Schließen des Bypassventils 19 und der Vorlauf- und Rücklaufventile 13, 14 mit durchgeführt werden.The described venting or rinsing process is automatically carried out cyclically during the treatment. In the disinfection of the hemodialysis machine, the sterile filter 6 can also be vented and flushed by cyclically closing the bypass valve 19 and the flow and return valves 13, 14.
Bei fehlerhaften Dialysat kann der Dialysatfluss durch Öffnen des Bypassventils 19 über die Bypassleitung 18 direkt von dem Einlass 10 des Sterilfilters 6 in die Ablaufleitung 2 geführt werden, ohne das dieses in das Sterilfilter 6 und den sicherheitskritischen Zweig der Dialysierflüssigkeit zwi- sehen der zweiten Kammer 9 des Sterilfilters 6 und dem Dialysator 4 gelangt. In the event of defective dialysate, the dialysate flow can be led directly from the inlet 10 of the sterile filter 6 into the outlet line 2 by opening the bypass valve 19 via the bypass line 18, without this flowing into the sterile filter 6 and the safety-critical branch of the dialysis fluid between the second chamber 9 of the sterile filter 6 and the dialyzer 4.

Claims

Ansprüche Expectations
1 . Hämodialysegerät mit einem zwischen einem Dialysierflussigkeitsweg und einem Blutweg (3) geschalteten Dialysator (4) und mit einem Sterilfilter (6) in dem Dialysierflussigkeitsweg, wobei das Sterilfilter1 . Hemodialysis machine with a dialyzer (4) connected between a dialysis fluid path and a blood path (3) and with a sterile filter (6) in the dialysis fluid path, the sterile filter
(6) durch eine Membran (7) in eine erste Kammer (8) und eine zweite Kammer (9) geteilt ist, und ein Einlass (10) der ersten Kammer (8) an eine Dialysierflüssigkeits-Zuleitung (1 ) und die zweite Kammer (9) an den Dialysator (4) angeschlossen ist, und wobei in dem Dialysierflüs- sigkeitsweg zwischen der zweiten Kammer (9) des Sterilfilters (6) und dem Dialysator (4) ein Absperrventil (13) vorgesehen ist, dadurch gekennzeichnet, dass ein Auslass (15) der ersten Kammer (8) des Sterilfilters (6) mit einem Rückschlagventil (16) an einen Ablauf (17) für die Dialysierflüssigkeit angeschlossen ist.(6) is divided by a membrane (7) into a first chamber (8) and a second chamber (9), and an inlet (10) of the first chamber (8) to a dialysis fluid supply line (1) and the second chamber (9) is connected to the dialyzer (4), and a shut-off valve (13) is provided in the dialyzing liquid path between the second chamber (9) of the sterile filter (6) and the dialyzer (4), characterized in that a Outlet (15) of the first chamber (8) of the sterile filter (6) with a check valve (16) is connected to an outlet (17) for the dialysis fluid.
2. Hämodialysegerät nach Anspruch 1 , dadurch gekennzeichnet, dass der Einlass (10) der ersten Kammer (8) des Sterilfilters (6) im Bereich eines ersten Endes des Sterilfilters (6) und der Auslass (15) der ersten Kammer (8) im Bereich eines zweiten Endes des Sterilfilters (6) angeordnet ist.2. Hemodialysis machine according to claim 1, characterized in that the inlet (10) of the first chamber (8) of the sterile filter (6) in the region of a first end of the sterile filter (6) and the outlet (15) of the first chamber (8) in Area of a second end of the sterile filter (6) is arranged.
3. Hämodialysegerät nach Anspruch 1 oder 2, dadurch gekennzeichnet, dass zwischen dem Auslass des Dialysators (4) und einer Ablaufleitung (2) für Dialysierflüssigkeit ein Absperrventil (14) vorgesehen ist.3. Hemodialysis machine according to claim 1 or 2, characterized in that a shut-off valve (14) is provided between the outlet of the dialyzer (4) and an outlet line (2) for dialysis fluid.
Hämodialysegerät nach einem der vorhergehenden Ansprüche, dadurch gekennzeichnet, dass der Einlass (10) der ersten Kammer (8) des Sterilfilters (6) mit einer Bypassleitung (18) und mit einem By- passventil (19) in der Bypassleitung (18) mit der Ablaufleitung (2) für die Dialysierflüssigkeit verbindbar ist. Hemodialysis machine according to one of the preceding claims, characterized in that the inlet (10) of the first chamber (8) of the sterile filter (6) with a bypass line (18) and with a by- pass valve (19) in the bypass line (18) can be connected to the drain line (2) for the dialysis fluid.
PCT/DE2003/003523 2002-11-20 2003-10-23 Haemodialysis unit WO2004045678A1 (en)

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DE10254099A DE10254099B3 (en) 2002-11-20 2002-11-20 Hemodialysing device, comprising mechanism for periodical rinsing working with pressure created by simultaneous closing of valves
DE10254099.3 2002-11-20

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS56158664A (en) 1980-05-10 1981-12-07 Daicel Ltd Purified water device connected to individual dialyzer
EP0270794B1 (en) 1986-12-08 1992-06-03 Fresenius AG Hemodialysis apparatus with sterilizing device
US5714060A (en) * 1995-02-13 1998-02-03 Aksys, Ltd. Disinfection of arterial and venous line connectors hemodialysis machine
EP0930080A1 (en) * 1998-01-19 1999-07-21 Fresenius AG Method and means for preparation of Dialysate
US6280632B1 (en) * 1997-01-09 2001-08-28 Gambro Lundia Ab Device and method for preparation of substitution solution

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2723002B1 (en) * 1994-07-26 1996-09-06 Hospal Ind DEVICE AND METHOD FOR PREPARING A FILTRATION PROCESSING LIQUID

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS56158664A (en) 1980-05-10 1981-12-07 Daicel Ltd Purified water device connected to individual dialyzer
EP0270794B1 (en) 1986-12-08 1992-06-03 Fresenius AG Hemodialysis apparatus with sterilizing device
US5714060A (en) * 1995-02-13 1998-02-03 Aksys, Ltd. Disinfection of arterial and venous line connectors hemodialysis machine
US6280632B1 (en) * 1997-01-09 2001-08-28 Gambro Lundia Ab Device and method for preparation of substitution solution
EP0930080A1 (en) * 1998-01-19 1999-07-21 Fresenius AG Method and means for preparation of Dialysate

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