EP4058090A1 - Dialysis machine for carrying out a push/pull-based dialysis treatment - Google Patents

Dialysis machine for carrying out a push/pull-based dialysis treatment

Info

Publication number
EP4058090A1
EP4058090A1 EP20804524.5A EP20804524A EP4058090A1 EP 4058090 A1 EP4058090 A1 EP 4058090A1 EP 20804524 A EP20804524 A EP 20804524A EP 4058090 A1 EP4058090 A1 EP 4058090A1
Authority
EP
European Patent Office
Prior art keywords
chamber
dialyzer
dialysis
dialysis machine
machine according
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
EP20804524.5A
Other languages
German (de)
French (fr)
Inventor
Tobias Irrgang
Peter KLÖFFEL
Benedict GLASER
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 EP4058090A1 publication Critical patent/EP4058090A1/en
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
    • A61M1/1621—Constructional aspects thereof
    • A61M1/1635—Constructional aspects thereof with volume chamber balancing devices between used and fresh dialysis fluid
    • A61M1/1639—Constructional aspects thereof with volume chamber balancing devices between used and fresh dialysis fluid linked by membranes
    • 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
    • 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
    • A61M1/1635—Constructional aspects thereof with volume chamber balancing devices between used and fresh dialysis fluid
    • 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
    • A61M1/1694—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes with recirculating dialysing liquid
    • 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
    • A61M1/34—Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
    • A61M1/3413—Diafiltration
    • 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
    • A61M1/34—Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
    • A61M1/342—Adding solutions to the blood, e.g. substitution solutions
    • A61M1/3424—Substitution fluid path
    • A61M1/3427—Substitution fluid path back through the membrane, e.g. by inverted trans-membrane pressure [TMP]
    • 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
    • A61M1/34—Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
    • A61M1/342—Adding solutions to the blood, e.g. substitution solutions
    • A61M1/3455—Substitution fluids
    • A61M1/3465—Substitution fluids using dialysate as substitution fluid

Definitions

  • the invention relates to a dialysis machine for carrying out a push-pull dialysis treatment.
  • the transmembrane pressure is therefore positive in the blood inlet area (the proximal area) of the dialyzer, which in this area leads to a net fluid transfer in the direction of the dialysate chamber of the dialyzer and a so-called forward filtration, and in the blood outlet area (the distal area) of the dialyzer negative, which in this area leads to a net fluid transfer in the direction of the blood chamber of the dialyzer and a so-called backward filtration.
  • the reverse filtration leads to a fluid balance and can be used to adjust the fluid loss, but it reduces the overall efficiency of the dialysis.
  • Forward filtration over the entire length of the dialyzer can also be achieved by lowering the dialysis fluid pressure relative to the blood pressure, as can reverse filtration over the entire length of the dialyzer by raising the dialysis fluid pressure relative to the blood pressure.
  • So-called push-pull processes use this fact to achieve alternating forward and backward filtration over the entire length of the dialyzer by varying the pressure. Overall, this can lead to an increase in the efficiency of the removal of uremia toxins from the blood.
  • Kyongsoo Lee (2013) Engineering perspective on the evolution of push / pull-based dialysis treatments, Expert Review of Medical Devices, 10: 5, 611-620 gives an overview of known options for implementing push-pull methods .
  • the object of the invention is to provide a dialysis machine with the ability to carry out a push-pull dialysis treatment, which is advantageous compared to known solutions.
  • the invention relates to a dialysis machine with a fluid system which has a supply line for providing fresh dialysis solution to a dialyzer and a discharge line for removing used dialysis solution from the dialyzer, the fluid system having a balancing system arranged between supply and discharge has to adjust the liquid volumes flowing through the lines, and wherein the fluid system has an ultrafiltration line branching off from the discharge line between the dialyzer and the balancing system with an ultrafiltration pump in order to be able to withdraw a defined volume of used dialysis solution from the adjustment.
  • an additional balancing chamber is provided which is arranged in a section of the supply line located between the balancing system and the dialyzer or a section of the discharge line located between the dialyzer and the branch of the ultrafiltration line.
  • the balancing chamber connects with one of its chambers the section of the supply line lying between the balancing system and the dialyzer with the section of the discharge line lying between the dialyzer and the branch of the ultrafiltration line.
  • the additional balancing chamber is not a balancing chamber in the strict sense, since it does not fulfill any balancing function. However, in terms of its structure, it is a balancing chamber, which is why this term is used in the present description.
  • the additional balancing chamber which is arranged close to the dialyzer, enables push-pull operation during dialysis treatment without the need for additional structural measures on the dialysis machine.
  • the additional balancing chamber has a preferably volume-rigid container, which is divided into two chambers by means of a preferably elastic membrane, with a connection for connecting the first chamber to the supply line and a connection for connecting the The first chamber is provided with the discharge line and a valve for opening and closing the respective connection is arranged on both connections.
  • connection for connecting the second chamber to a fluid control pump is provided on the other of the chambers, i.e. the second chamber, with which the pressure in the second chamber can be increased or decreased
  • the connection in front preferably has a valve for its opening and closing.
  • the fluid control pump can be designed so that it can convey fluids in two directions.
  • two connections can be provided on the second chamber for connecting the second chamber to one fluid control pump each, wherein the pressure in the second chamber can be increased or decreased using the fluid control pumps.
  • one of the liquid control pumps is preferably designed in such a way that it can convey liquids into the second chamber, and the other of the liquid control pumps preferably designed so that it can draw liquids from the second chamber.
  • the at least one fluid control pump is provided to convey fluid into the second chamber of the additional balancing chamber or to remove fluid from this chamber.
  • the liquid used is preferably moved back and forth in pendulum mode. It thus serves to move the membrane of the additional balance chamber, so that dialysis fluid can be conveyed in the dialyzer in push-pull operation in the first chamber.
  • connection or connections of the second chamber can also be made for the connection or connections of the second chamber to be provided with valves for opening and closing the respective connection. This enables particularly precise control of the push-pull process.
  • the valves can be, for example, electrically controllable 2/2-way solenoid valves, with the aid of which the connections can either be completely opened or closed.
  • the dialysis machine has a control unit which is in signal connection with the valves of the additional balance chamber and the fluid control pump (s) and is designed to control the valves and pumps in such a way that the pressure of the dialysis solution in the dialyzer is caused by alternating filling and emptying the one chamber of the additional balance chamber with dialysis solution from supply and discharge is periodically raised and lowered.
  • a control unit which is in signal connection with the valves of the additional balance chamber and the fluid control pump (s) and is designed to control the valves and pumps in such a way that the pressure of the dialysis solution in the dialyzer is caused by alternating filling and emptying the one chamber of the additional balance chamber with dialysis solution from supply and discharge is periodically raised and lowered.
  • control unit can be designed, in a treatment phase, to open the valve connecting the first chamber to the supply line, to close the valve connecting the first chamber to the discharge line and to activate the fluid control pump (s) to increase the pressure in the second chamber, to increase the inlet pressure of the dialysis solution at the dialyzer.
  • the fluid control pump s
  • the fluid pressure of the dialysis solution in the dialyzer is increased overall, which increases the proportion of backward filtration in the dialyzer.
  • control unit can in particular be designed to open the valve connecting the first chamber to the discharge line, to close the valve connecting the first chamber to the supply line and to activate the fluid control pump (s) to reduce the pressure in the second chamber to reduce the outlet pressure of the dialysis solution at the dialyzer.
  • the described treatment phases for increasing the inlet pressure or for reducing the outlet pressure are preferably selected alternately by the control unit, with either a pause or a direct transition between the treatment phases.
  • the fluid system has an air separator arranged between the dialyzer and the balancing system in the discharge line and the additional balancing chamber is arranged between the balancing system and the dialyzer and a section of the supply line located between the dialyzer and the air separator.
  • the air separator can be arranged, for example, on or in the area of the branching off of the ultrafiltration line on the discharge line.
  • the balancing device of the dialysis machine can be a balancing chamber system with two balancing chambers.
  • the machine or, more precisely, its fluid system comprises in this embodiment at least three balancing chambers, two of which are actually part of a balancing system, while the additional balancing chamber does not fulfill a balancing function, but enables push-pull operation.
  • the device according to the invention can in principle be designed to carry out a hemodialysis treatment or a hemodiafiltration treatment, the concept according to the invention being particularly suitable for use in the context of a hemodialysis treatment due to the pressure differences that can be achieved.
  • a method for treating a dialysis patient using a dialysis machine according to the invention is proposed, a first treatment period without push-pull operation and a second treatment period with push-pull operation being provided.
  • the first treatment period there is still a large amount of uremia toxins in the dialysate, so that the efficiency of the push-pull method is not yet optimal.
  • This period can be 20 minutes to approximately 2.5 hours, a period of time between 30 minutes and 1 hour is preferred.
  • This is followed by a second treatment period with push-pull operation, so that highly efficient treatment is made possible. The quality of treatment is thus optimized.
  • a device for enabling a push-pull procedure is integrated into the dialysis machine by arranging a further balance chamber near the dialyzer. With this dialysis solution can then be transported back and forth. As part of a push-pull procedure on a device according to the invention, used dialysis solution is also pushed back into the dialyzer.
  • a main advantage over known devices is in particular the simple structure. No external devices are required that have to be integrated into the machine or the disposable. To implement the idea of the invention, only the machine-side arrangement of a further balancing chamber is required. Further details and advantages of the invention emerge from the exemplary embodiment illustrated below with reference to the figures. In the figures show:
  • FIG. 1 a schematic representation of the fluid system of a dialysis machine according to the invention
  • FIG. 2 an enlarged illustration of the area around the additional fluid chamber of this system
  • FIGS. 3a-3f representations of the configuration of the area shown in FIG. 2 in different phases of the treatment.
  • FIG. 4 an enlarged illustration of the area around the additional fluid chamber of a further embodiment of a dialysis machine according to the invention.
  • FIG. 1 shows a schematic representation of the fluid system 100 of a dialysis machine according to the invention, which is connected to a dialyzer 200.
  • the fluid system 100 comprises a supply line 110 for providing fresh dialysis solution to the dialyzer 200 and a discharge line 120 for removing used dialysis solution from the dialyzer 200.
  • a balancing chamber system 130 is arranged between the lines 110 and 120 and between the dialyzer 200 and this balancing system 130 branches off from the discharge line 120 from an ultrafiltration line 140 in which an ultrafiltration pump 141 is arranged.
  • An air separator 150 is provided in the area of the junction.
  • the fluid system 100 comprises an additional balancing chamber 160, which is located between the balancing system 130 and the dialyzer 200 connects the section of the supply line 110 to a section of the discharge line 120 lying between the dialyzer 200 and the branch of the ultrafiltration line 140.
  • the volume-rigid balance chamber 160 is divided into two chambers K1 and K2 using an elastic membrane 161 and has four connections A1, A2, A3 and A4, each of which has an electronically controllable solenoid valve V1, V2, V3 or V4 for opening and closing the respective Connection is arranged, wherein the solenoid valves V1 and V4 are to be regarded as optional and could also be omitted.
  • the second connection A2 connects the chamber K2 to the supply line 110 and the third connection A3 connects the chamber K2 to the discharge line 120.
  • the chamber K1 is connected at the connections A1 and A4 with a liquid regulating gel pump 170 and 180, respectively, which in turn are connected to reservoirs 171 and 181, respectively. With the aid of these pumps 170 and 180, the liquid pressure in the chamber K1 can be varied and thus ultimately a push-pull operation can be implemented, as will be explained in more detail below.
  • FIG. 3a shows a possible starting position in which all valves V1-V4 are closed, in which both chambers K1 and K2 are filled with dialysis solution or liquid and in which the membrane 161 is in a starting position.
  • the valves V1 and V2 are opened, the membrane 161 can be pressed into the chamber K2 by the pressure in the chamber K1, which is higher than the pressure in the chamber K2, when the pressure builds up accordingly.
  • dialysis solution is displaced from the chamber K2 in the direction of the feed line 110 and the dialysate flow is increased.
  • the proportion of backward filtration in the dialyzer 200 is also increased compared to the starting position, since the inlet pressure and thus also the overall pressure of the dialysis solution at the dialyzer 200 is increased.
  • valves V1 and V2 are closed and instead the valves V3 and V4 are opened, the membrane 161 becomes higher in relation to the pressure in the chamber K1 during the suction operation of the pump 180 Pressure in chamber K2 pushed back into chamber K1. Since the chamber K2 is filled with used dialysis solution, while the liq fluid is displaced from the chamber K1 in the direction of the reservoir 181. Thus, in this constellation, the proportion of forward filtration in the dialyzer 200 is increased compared to the initial position, since the initial pressure and thus also the overall pressure of the dialysis solution at the dialyzer 200 is reduced.
  • the used dialysis solution is displaced from the chamber K2 in the direction of the supply line 110, so that the process according to the invention not only achieves a push-pull effect, but also means that part of the used dialysis solution is reused.
  • FIG. 1 A variant of the embodiment shown in FIGS. 1-3 is shown in FIG.
  • the connection A4, the valve V4, the pump 180 and the reservoir 181 are absent.
  • the pump 170 is designed as a bidirectional pump with which the pressure in the chamber K1 is to be increased and decreased.
  • Each opening of the valve V4 described above for the embodiment variant according to FIGS. 1-3 when the pump 180 is in operation is thus replaced in this embodiment variant by an opening of the valve V1 and a suction operation of the pump 170.

Abstract

The invention relates to a dialysis machine comprising a fluid system, which has a supply line for providing fresh dialysis solution to a dialyser and a discharge line for removing used dialysis solution from the dialyser, wherein the fluid system has a balancing system arranged between the supply and discharge lines in order to balance the fluid volumes flowing through the lines, wherein the fluid system has an ultrafiltration line branching off the discharge line between the dialyser and the balancing system and having an ultrafiltration pump in order to be able to withdraw a defined volume of used dialysis solution from the balance process, and wherein an additional balancing chamber is provided, which is arranged in a section of the supply line located between the balancing system and the dialyser or a section of the discharge line located between the dialyser and the branch of the ultrafiltration line.

Description

Dialysemaschine zur Durchführung einer Push-Pull-Dialysebehandlung Dialysis machine for carrying out a push-pull dialysis treatment
Die Erfindung betrifft eine Dialysemaschine zur Durchführung einer Push-Pull- Dialysebehandlung. The invention relates to a dialysis machine for carrying out a push-pull dialysis treatment.
In der Hämodialyse bzw. Hämodiafiltration wird der Dialysator gegenläufig von Blut und Dialysierlösung durchströmt. Durch das Gegenstromprinzip ist der Blutdruck im Verhältnis zum Dialysierlösung bluteingangsseitig des Dialysators größer als blut ausgangsseitig des Dialysators. Bei typischer Verfahrensführung ist der Trans membrandruck daher im Bluteingangsbereich (dem proximalen Bereich) des Dialy sators positiv, was in diesem Bereich zu einem Netto-Flüssigkeitstransfer in Rich tung der Dialysatkammer des Dialysators und einer sogenannten Vorwärtsfiltration führt, und im Blutausgangsbereich (dem distalen Bereich) des Dialysators negativ, was in diesem Bereich zu einem Netto-Flüssigkeitstransfer in Richtung der Blut kammer des Dialysators und einer sogenannten Rückwärtsfiltration führt. Die Rückwärtsfiltration führt zwar zu einem Flüssigkeitsausgleich und kann zur Einstel lung des Flüssigkeitsverlusts genützt werden, verringert aber insgesamt den Wir kungsgrad der Dialyse. Eine Vorwärtsfiltration über die gesamte Länge des Dialysators kann durch ein Ab senken des Dialysierflüssigkeitsdrucks relativ zum Blutdruck ebenso erreicht wer den wie eine Rückwärtsfiltration über die gesamte Länge des Dialysators durch ein Anheben des Dialysierflüssigkeitsdrucks relativ zum Blutdruck. Sogenannte Push- Pull-Verfahren nützen diesen Umstand, um durch Druckvariation abwechselnd eine Vorwärts- und eine Rückwärtsfiltration über die gesamte Länge des Dialysators zu erreichen. Dies kann insgesamt zu einer Effizienzsteigerung bei der Entfernung von Urämietoxinen aus dem Blut führen. Einen Überblick über bekannte Möglichkeiten der Implementierung von Push-Pull-Verfahren gibt der Review-Artikel Kyongsoo Lee (2013) Engineering perspective on the evolution of push/pull-based dialysis treatments, Expert Review of Medical Devices, 10:5, 611-620. In hemodialysis or hemodiafiltration, blood and dialysis solution flow through the dialyzer in opposite directions. Due to the countercurrent principle, the blood pressure in relation to the dialysis solution on the blood inlet side of the dialyzer is greater than that on the blood outlet side of the dialyzer. In a typical procedure, the transmembrane pressure is therefore positive in the blood inlet area (the proximal area) of the dialyzer, which in this area leads to a net fluid transfer in the direction of the dialysate chamber of the dialyzer and a so-called forward filtration, and in the blood outlet area (the distal area) of the dialyzer negative, which in this area leads to a net fluid transfer in the direction of the blood chamber of the dialyzer and a so-called backward filtration. The reverse filtration leads to a fluid balance and can be used to adjust the fluid loss, but it reduces the overall efficiency of the dialysis. Forward filtration over the entire length of the dialyzer can also be achieved by lowering the dialysis fluid pressure relative to the blood pressure, as can reverse filtration over the entire length of the dialyzer by raising the dialysis fluid pressure relative to the blood pressure. So-called push-pull processes use this fact to achieve alternating forward and backward filtration over the entire length of the dialyzer by varying the pressure. Overall, this can lead to an increase in the efficiency of the removal of uremia toxins from the blood. The review article Kyongsoo Lee (2013) Engineering perspective on the evolution of push / pull-based dialysis treatments, Expert Review of Medical Devices, 10: 5, 611-620 gives an overview of known options for implementing push-pull methods .
Aufgabe der Erfindung ist es, ein Dialysegerät mit der Fähigkeit zur Durchführung einer Push-Pull-Dialysebehandlung bereitzustellen, das im Vergleich zu bekannten Lösungen vorteilhaft ist. The object of the invention is to provide a dialysis machine with the ability to carry out a push-pull dialysis treatment, which is advantageous compared to known solutions.
Vor diesem Hintergrund betrifft die Erfindung eine Dialysemaschine mit einem Flu idsystem, das eine Zuleitung zur Bereitstellung von frischer Dialysierlösung an ei nen Dialysator und eine Ableitung zur Entfernung von verbrauchter Dialysierlösung aus dem Dialysator aufweist, wobei das Fluidsystem ein zwischen Zu- und Ablei tung angeordnetes Bilanziersystem aufweist, um die durch die Leitungen fließen den Flüssigkeitsvolumina abzugleichen, und wobei das Fluidsystem eine zwischen dem Dialysator und dem Bilanziersystem von der Ableitung abzweigende Ultrafiltra tionsleitung mit einer Ultrafiltrationspumpe aufweist, um dem Abgleich ein definier tes Volumen an verbrauchter Dialysierlösung entziehen zu können. Against this background, the invention relates to a dialysis machine with a fluid system which has a supply line for providing fresh dialysis solution to a dialyzer and a discharge line for removing used dialysis solution from the dialyzer, the fluid system having a balancing system arranged between supply and discharge has to adjust the liquid volumes flowing through the lines, and wherein the fluid system has an ultrafiltration line branching off from the discharge line between the dialyzer and the balancing system with an ultrafiltration pump in order to be able to withdraw a defined volume of used dialysis solution from the adjustment.
Erfindungsgemäß ist eine zusätzliche Bilanzkammer vorgesehen, welche in einem zwischen dem Bilanziersystem und dem Dialysator liegenden Abschnitt der Zulei tung bzw. einem zwischen dem Dialysator und der Abzweigung der Ultrafiltrations leitung liegenden Abschnitt der Ableitung angeordnet ist. Die Bilanzkammer verbindet mit einer ihrer Kammern den zwischen dem Bilanzier system und dem Dialysator liegenden Abschnitt der Zuleitung mit dem zwischen dem Dialysator und der Abzweigung der Ultrafiltrationsleitung liegenden Abschnitt der Ableitung. According to the invention, an additional balancing chamber is provided which is arranged in a section of the supply line located between the balancing system and the dialyzer or a section of the discharge line located between the dialyzer and the branch of the ultrafiltration line. The balancing chamber connects with one of its chambers the section of the supply line lying between the balancing system and the dialyzer with the section of the discharge line lying between the dialyzer and the branch of the ultrafiltration line.
Die zusätzliche Bilanzkammer ist keine Bilanzkammer im eigentlichen Sinn, da sie keine Bilanzierfunktion erfüllt. Sie ist aber dem Aufbau nach eine Bilanzkammer, weshalb in der vorliegenden Beschreibung auf diesen Begriff zurückgegriffen wird. Die dialysatornah angeordnete, zusätzliche Bilanzkammer ermöglicht einen Push- Pull-Betrieb während der Dialysebehandlung, ohne dass zusätzliche bauliche Maß nahmen an der Dialysemaschine erforderlich sind. The additional balancing chamber is not a balancing chamber in the strict sense, since it does not fulfill any balancing function. However, in terms of its structure, it is a balancing chamber, which is why this term is used in the present description. The additional balancing chamber, which is arranged close to the dialyzer, enables push-pull operation during dialysis treatment without the need for additional structural measures on the dialysis machine.
Insbesondere kann vorgesehen sein, dass die zusätzliche Bilanzkammer ein vor zugsweise volumenstarres Behältnis aufweist, das anhand einer vorzugsweise elastischen Membran in zwei Kammern unterteilt ist, wobei an einer ersten der Kammern ein Anschluss zur Verbindung der ersten Kammer mit der Zuleitung und ein Anschluss zur Verbindung der ersten Kammer mit der Ableitung vorgesehen ist und wobei an beiden Anschlüssen ein Ventil zum Öffnen und Schließen des jewei ligen Anschlusses angeordnet ist. In particular, it can be provided that the additional balancing chamber has a preferably volume-rigid container, which is divided into two chambers by means of a preferably elastic membrane, with a connection for connecting the first chamber to the supply line and a connection for connecting the The first chamber is provided with the discharge line and a valve for opening and closing the respective connection is arranged on both connections.
Weiter vorzugsweise ist vorgesehen, dass an der anderen der Kammern, also der zweiten Kammer wenigstens ein Anschluss zur Verbindung der zweiten Kammer mit einer Flüssigkeitssteuerpumpe vor-gesehen ist, mit welcher der Druck in der zweiten Kammer erhöht oder erniedrigt werden kann, wobei der Anschluss vor zugsweise ein Ventil zu dessen Öffnen und Schließen aufweist. Die Flüssigkeits steuerpumpe kann dabei so ausgebildet sein, dass sie Flüssigkeiten in zwei Rich tungen fördern kann. Alternativ können an der zweiten Kammer zwei Anschlüsse zur Verbindung der zweiten Kammer mit jeweils einer Flüssigkeitssteuerpumpe vorgesehen sein, wobei anhand der Flüssigkeitssteuerpumpen der Druck in der zweiten Kammer erhöht oder erniedrigt werden kann. In diesem Fall ist eine der Flüssigkeitssteuerpumpen vorzugsweise so ausgebildet, dass sie Flüssigkeiten in die zweite Kammer fördern kann, und die andere der Flüssigkeitssteuerpumpen vorzugsweise so ausgebildet, dass sie Flüssigkeiten aus der zweiten Kammer zie hen kann. It is further preferably provided that at least one connection for connecting the second chamber to a fluid control pump is provided on the other of the chambers, i.e. the second chamber, with which the pressure in the second chamber can be increased or decreased, the connection in front preferably has a valve for its opening and closing. The fluid control pump can be designed so that it can convey fluids in two directions. Alternatively, two connections can be provided on the second chamber for connecting the second chamber to one fluid control pump each, wherein the pressure in the second chamber can be increased or decreased using the fluid control pumps. In this case, one of the liquid control pumps is preferably designed in such a way that it can convey liquids into the second chamber, and the other of the liquid control pumps preferably designed so that it can draw liquids from the second chamber.
Die mindestens eine Flüssigkeitssteuerpumpe ist dazu vorgesehen, Flüssigkeit in die zweite Kammer der zusätzlichen Bilanzkammer zu fördern bzw. Flüssigkeit aus dieser Kammer zu entfernen. Dabei wird die verwendete Flüssigkeit bevorzugt im Pendelbetrieb hin- und her bewegt. Sie dient somit zur Bewegung der Membran der zusätzlichen Bilanzkammer, so dass in der ersten Kammer Dialysierflüssigkeit im Push-Pull- Betrieb im Dialysator gefördert werden kann. The at least one fluid control pump is provided to convey fluid into the second chamber of the additional balancing chamber or to remove fluid from this chamber. The liquid used is preferably moved back and forth in pendulum mode. It thus serves to move the membrane of the additional balance chamber, so that dialysis fluid can be conveyed in the dialyzer in push-pull operation in the first chamber.
Es kann weiterhin vorgesehen sein, den Anschluss bzw. die Anschlüsse der zwei ten Kammer mit Ventilen zum Öffnen und Schließen des jeweiligen Anschlusses zu versehen. Dies ermöglicht ein besonders präzises Steuern des Push-Pull- Vorgan ges. Provision can also be made for the connection or connections of the second chamber to be provided with valves for opening and closing the respective connection. This enables particularly precise control of the push-pull process.
Bei den Ventilen kann es sich beispielsweise um elektrisch ansteuerbare 2/2-Wege Magnetventile handeln, anhand derer die Anschlüsse wahlweise vollständig geöff net oder geschlossen werden können. The valves can be, for example, electrically controllable 2/2-way solenoid valves, with the aid of which the connections can either be completely opened or closed.
Die Dialysemaschine weist in einer bevorzugten Ausführungsform eine Steuerein heit auf, die mit den Ventilen der zusätzlichen Bilanzkammer und der oder den Flüssigkeitssteuerpumpen in Signalverbindung steht und ausgebildet ist, die Ventile und Pumpen so anzusteuern, dass der Druck der Dialysierlösung im Dialysator durch abwechselnde Befüllung und Entleerung der einen Kammer der zusätzlichen Bilanzkammer mit Dialysierlösung aus Zu- und Ableitung periodisch angehoben und abgesenkt wird. In a preferred embodiment, the dialysis machine has a control unit which is in signal connection with the valves of the additional balance chamber and the fluid control pump (s) and is designed to control the valves and pumps in such a way that the pressure of the dialysis solution in the dialyzer is caused by alternating filling and emptying the one chamber of the additional balance chamber with dialysis solution from supply and discharge is periodically raised and lowered.
Insbesondere kann die Steuereinheit ausgebildet sein, in einer Behandlungsphase das die erste Kammer mit der Zuleitung verbindende Ventil zu öffnen, das die erste Kammer mit der Ableitung verbindende Ventil zu schließen und die Flüssigkeits- steuerpumpe(n) zur Druckerhöhung in der zweiten Kammer zu aktivieren, um den Eingangsdruck der Dialysierlösung am Dialysator zu erhöhen. Durch Erhöhung des Eingangsdrucks bei gleichbleibendem Ausgangsdruck wird der Fluiddruck der Dia- lysierlösung im Dialysator insgesamt erhöht, was den Anteil der Rückwärtsfiltration im Dialysator erhöht. Entsprechend kann die Steuereinheit insbesondere ausgebil det sein, in einer Behandlungsphase das die erste Kammer mit der Ableitung ver bindende Ventil zu öffnen, das die erste Kammer mit der Zuleitung verbindende Ventile zu schließen und die Flüssigkeitssteuerpumpe(n) zur Druckverringerung in der zweiten Kammer zu aktivieren, um den Ausgangsdruck der Dialysierlösung am Dialysator zu verringern. Durch Verringerung des Ausgangsdrucks bei gleichblei bendem Eingangsdruck wird der Fluiddruck der Dialysierlösung im Dialysator ins gesamt verringert, was den Anteil der Vorwärtsfiltration im Dialysator erhöht. In particular, the control unit can be designed, in a treatment phase, to open the valve connecting the first chamber to the supply line, to close the valve connecting the first chamber to the discharge line and to activate the fluid control pump (s) to increase the pressure in the second chamber, to increase the inlet pressure of the dialysis solution at the dialyzer. By increasing the At the inlet pressure with the outlet pressure remaining the same, the fluid pressure of the dialysis solution in the dialyzer is increased overall, which increases the proportion of backward filtration in the dialyzer. Accordingly, the control unit can in particular be designed to open the valve connecting the first chamber to the discharge line, to close the valve connecting the first chamber to the supply line and to activate the fluid control pump (s) to reduce the pressure in the second chamber to reduce the outlet pressure of the dialysis solution at the dialyzer. By reducing the outlet pressure while the inlet pressure remains constant, the fluid pressure of the dialysis solution in the dialyzer is reduced overall, which increases the proportion of forward filtration in the dialyzer.
Die geschilderten Behandlungsphasen zur Erhöhung des Eingangsdrucks bzw. zur Verringerung des Ausgangsdrucks werden von der Steuereinheit vorzugsweise abwechselnd angewählt, wobei zwischen den Behandlungsphasen wahlweise ent weder eine Pause stattfinden oder der Übergang direkt sein kann. The described treatment phases for increasing the inlet pressure or for reducing the outlet pressure are preferably selected alternately by the control unit, with either a pause or a direct transition between the treatment phases.
In einer Ausführungsform weist das Fluidsystem einen zwischen dem Dialysator und dem Bilanziersystem in der Ableitung angeordneten Luftabscheider auf und die zusätzliche Bilanzkammer ist zwischen dem Bilanziersystem und dem Dialysator liegenden Abschnitt der Zuleitung und einem zwischen dem Dialysator und dem Luftabscheider liegenden Abschnitt der Ableitung angeordnet. Der Luftabscheider kann beispielsweise an oder im Bereich der Abzweigung der Ultrafiltrationsleitung an der Ableitung angeordnet sein. In one embodiment, the fluid system has an air separator arranged between the dialyzer and the balancing system in the discharge line and the additional balancing chamber is arranged between the balancing system and the dialyzer and a section of the supply line located between the dialyzer and the air separator. The air separator can be arranged, for example, on or in the area of the branching off of the ultrafiltration line on the discharge line.
Bei der Bilanzierungsvorrichtung der Dialysemaschine kann es sich um ein Bilanz kammersystem mit zwei Bilanzkammern handeln. Die Maschine bzw. genauer ge sagt deren Fluidsystem umfasst in dieser Ausführungsform also wenigstens drei Bilanzkammern, wovon zwei Bilanzkammern tatsächlich einen Teil eines Bilanzier systems darstellen, während die zusätzliche Bilanzkammer keine Bilanzierfunktion erfüllt, sondern einen Push-Pull-Betrieb ermöglicht. Die erfindungsgemäße Vorrichtung kann grundsätzlich zur Durchführung einer Hä modialysebehandlung oder eine Hämodiafiltrationsbehandlung ausgebildet sein, wobei das erfindungsgemäße Konzept aufgrund der erreichbaren Druckunterschie de insbesondere für eine Anwendung im Rahmen einer Hämodialysebehandlung geeignet ist. Es ermöglicht eine erhöhte Substituatzuführung über die Dialyse membran und eine erhöhte Entfernung von Urämtoxinden, ohne dass eine aufwän dige Bereitstellung einer Substituatleitung und Substituatherstellung wie bei der Hämodiafiltration notwendig wird. Es wird dadurch eine besonders hohe Entfernung von Urämtoxinen mit geringem Aufwand erzielt. The balancing device of the dialysis machine can be a balancing chamber system with two balancing chambers. The machine or, more precisely, its fluid system comprises in this embodiment at least three balancing chambers, two of which are actually part of a balancing system, while the additional balancing chamber does not fulfill a balancing function, but enables push-pull operation. The device according to the invention can in principle be designed to carry out a hemodialysis treatment or a hemodiafiltration treatment, the concept according to the invention being particularly suitable for use in the context of a hemodialysis treatment due to the pressure differences that can be achieved. It enables an increased supply of substituate via the dialysis membrane and an increased removal of uremotoxins without the need for a complex provision of a substituate line and substituate production as is the case with hemodiafiltration. This achieves a particularly high removal of uremic toxins with little effort.
In einem weiteren Aspekt der Erfindung wird ein Verfahren zur Behandlung eines Dialysepatienten unter Verwendung einer erfindungsgemäßen Dialysemaschine vorgeschlagen, wobei eine erste Behandlungsperiode ohne Push-Pull- Betrieb und eine zweite Behandlungsperiode mit Push- Pull- Betrieb vorgesehen ist. In der ers ten Behandlungsperiode fällt im Dialysat noch eine große Menge Urämtoxine an, so dass die Effizienz der Push- Pull- Methode noch nicht optimal ist. Diese Periode kann 20 min. bis ca. 2,5 h betragen, bevorzugt ist eine Zeitspanne zwischen 30 min. und 1 h. Daran schließt sich eine zweite Behandlungsperiode mit Push- Pull- Betrieb an, so dass eine hocheffiziente Behandlung ermöglicht wird. Die Behand lungsqualität wird somit optimiert. In a further aspect of the invention, a method for treating a dialysis patient using a dialysis machine according to the invention is proposed, a first treatment period without push-pull operation and a second treatment period with push-pull operation being provided. In the first treatment period there is still a large amount of uremia toxins in the dialysate, so that the efficiency of the push-pull method is not yet optimal. This period can be 20 minutes to approximately 2.5 hours, a period of time between 30 minutes and 1 hour is preferred. This is followed by a second treatment period with push-pull operation, so that highly efficient treatment is made possible. The quality of treatment is thus optimized.
Zusammenfassend kann also festgehalten werden, dass erfindungsgemäß eine Vorrichtung zur Ermöglichung einer Push-Pull-Verfahrensführung in die Dialysema schine integriert wird, indem eine weitere Bilanzkammer nahe dem Dialysator an geordnet wird. Mit dieser kann dann Dialysierlösung hin und her befördert werden. Im Rahmen einer Push-Pull-Verfahrensführung an einer erfindungsgemäßen Vor richtung wird auch gebrauchte Dialysierlösung in den Dialysator zurückgeschoben. Ein Hauptvorteil gegenüber bekannten Vorrichtungen liegt insbesondere im einfa chen Aufbau. Es werden keine externen Vorrichtungen benötigt, die zusätzlich in die Maschine oder das Disposable integriert werden müssen. Zur Umsetzung des Erfindungsgedankens ist lediglich die maschinenseitige Anordnung einer weiteren Bilanzkammer erforderlich. Weitere Einzelheiten und Vorteile der Erfindung ergeben sich aus dem nachfolgend anhand der Figuren dargestellten Ausführungsbeispiel. In den Figuren zeigen: In summary, it can be stated that, according to the invention, a device for enabling a push-pull procedure is integrated into the dialysis machine by arranging a further balance chamber near the dialyzer. With this dialysis solution can then be transported back and forth. As part of a push-pull procedure on a device according to the invention, used dialysis solution is also pushed back into the dialyzer. A main advantage over known devices is in particular the simple structure. No external devices are required that have to be integrated into the machine or the disposable. To implement the idea of the invention, only the machine-side arrangement of a further balancing chamber is required. Further details and advantages of the invention emerge from the exemplary embodiment illustrated below with reference to the figures. In the figures show:
Figur 1 : eine schematische Darstellung des Fluidsystems einer erfin dungsgemäßen Dialysemaschine; FIG. 1: a schematic representation of the fluid system of a dialysis machine according to the invention;
Figur 2: eine vergrößerte Darstellung des Bereichs rund um die zusätzli che Fluidkammer dieses Systems; FIG. 2: an enlarged illustration of the area around the additional fluid chamber of this system;
Figuren 3a-3f: Darstellungen der Konfiguration des in Figur 2 gezeigten Be reichs in unterschiedlichen Phasen der Behandlung; und FIGS. 3a-3f: representations of the configuration of the area shown in FIG. 2 in different phases of the treatment; and
Figur 4: eine vergrößerte Darstellung des Bereichs rund um die zusätzli che Fluidkammer einer weiteren Ausführungsform einer erfin dungsgemäßen Dialysemaschine. FIG. 4: an enlarged illustration of the area around the additional fluid chamber of a further embodiment of a dialysis machine according to the invention.
Figur 1 zeigt eine schematische Darstellung des Fluidsystems 100 einer erfin dungsgemäßen Dialysemaschine, das mit einem Dialysator 200 in Verbindung steht. FIG. 1 shows a schematic representation of the fluid system 100 of a dialysis machine according to the invention, which is connected to a dialyzer 200.
Das Fluidsystem 100 umfasst eine Zuleitung 110 zur Bereitstellung von frischer Dialysierlösung an den Dialysator 200 und eine Ableitung 120 zur Entfernung von verbrauchter Dialysierlösung aus dem Dialysator 200. Zwischen den Leitungen 110 und 120 ist ein Bilanzkammersystem 130 angeordnet und zwischen dem Dialysator 200 und diesem Bilanziersystem 130 zweigt von der Ableitung 120 eine Ultrafiltrati onsleitung 140 ab, in welcher eine Ultrafiltrationspumpe 141 angeordnet ist. Im Be reich der Abzweigung ist ein Luftabscheider 150 vorgesehen. Aufbau und Funktion der genannten Bestandteile sind bekannt und müssen nicht näher erläutert werden. The fluid system 100 comprises a supply line 110 for providing fresh dialysis solution to the dialyzer 200 and a discharge line 120 for removing used dialysis solution from the dialyzer 200. A balancing chamber system 130 is arranged between the lines 110 and 120 and between the dialyzer 200 and this balancing system 130 branches off from the discharge line 120 from an ultrafiltration line 140 in which an ultrafiltration pump 141 is arranged. An air separator 150 is provided in the area of the junction. The structure and function of the components mentioned are known and do not need to be explained in more detail.
Erfindungsgemäß umfasst das Fluidsystem 100 eine zusätzliche Bilanzkammer 160, die einen zwischen dem Bilanziersystem 130 und dem Dialysator 200 liegen- den Abschnitt der Zuleitung 110 mit einem zwischen dem Dialysator 200 und der Abzweigung der Ultrafiltrationsleitung 140 liegenden Abschnitt der Ableitung 120 verbindet. According to the invention, the fluid system 100 comprises an additional balancing chamber 160, which is located between the balancing system 130 and the dialyzer 200 connects the section of the supply line 110 to a section of the discharge line 120 lying between the dialyzer 200 and the branch of the ultrafiltration line 140.
Der Bereich um diese zusätzliche Bilanzkammer 160 ist in Figur 2 vergrößert dar gestellt. The area around this additional balancing chamber 160 is shown enlarged in FIG.
Die volumenstarre Bilanzkammer 160 ist anhand einer elastischen Membran 161 in zwei Kammern K1 und K2 unterteilt und hat vier Anschlüsse A1, A2, A3 und A4, an denen jeweils ein elektronisch ansteuerbares Magnetventil V1 , V2, V3 bzw. V4 zum Öffnen und Schließen des jeweiligen Anschlusses angeordnet ist, wobei die Mag netventile V1 und V4 als optional zu betrachten sind und auch weggelassen werden könnten. The volume-rigid balance chamber 160 is divided into two chambers K1 and K2 using an elastic membrane 161 and has four connections A1, A2, A3 and A4, each of which has an electronically controllable solenoid valve V1, V2, V3 or V4 for opening and closing the respective Connection is arranged, wherein the solenoid valves V1 and V4 are to be regarded as optional and could also be omitted.
Jedenfalls verbindet der zweite Anschluss A2 die Kammer K2 mit der Zuleitung 110 und der dritte Anschluss A3 die Kammer K2 mit der Ableitung 120. In any case, the second connection A2 connects the chamber K2 to the supply line 110 and the third connection A3 connects the chamber K2 to the discharge line 120.
Die Kammer K1 ist an den Anschlüssen A1 und A4 mit jeweils einer Flüssigkeitsre gelpumpe 170 bzw. 180 verbunden, die ihrerseits mit Reservoirs 171 bzw. 181 in Verbindung stehen. Anhand dieser Pumpen 170 und 180 kann der Flüssigkeits druck in der Kammer K1 variiert und somit letztlich ein Push-Pull-Betrieb realisiert werden, wie es im folgenden noch näher erklärt werden wird. The chamber K1 is connected at the connections A1 and A4 with a liquid regulating gel pump 170 and 180, respectively, which in turn are connected to reservoirs 171 and 181, respectively. With the aid of these pumps 170 and 180, the liquid pressure in the chamber K1 can be varied and thus ultimately a push-pull operation can be implemented, as will be explained in more detail below.
Der Ablauf einer Push-Pull-Dialysebehandlung an einer derart aufgebauten Dialy semaschine lässt sich anhand der Figuren 3a-3f nachvollziehen. The sequence of a push-pull dialysis treatment on a dialysis machine constructed in this way can be understood with the aid of FIGS. 3a-3f.
Figur 3a zeigt eine mögliche Ausgangsstellung, in welcher alle Ventile V1-V4 ge schlossen sind, in welcher beide Kammern K1 und K2 mit Dialysierlösung bzw. Flüssigkeit gefüllt sind und in welcher die Membran 161 sich in einer Ausgangsstel lung befindet. Werden, wie in Figur 3b gezeigt, die Ventile V1 und V2 geöffnet, so kann die Membran 161 bei entsprechendem Druckaufbau durch die Pumpe 170 durch den im Verhältnis zum Druck in der Kammer K2 höheren Druck in der Kammer K1 in die Kammer K2 gedrückt. Dabei wird Dialysierlösung aus der Kammer K2 in Richtung der Zuleitung 110 verdrängt und der Dialysatfluss erhöht. Somit wird in dieser Konstellation auch der Anteil der Rückwärtsfiltration im Dialysator 200 gegenüber der Ausgangsstellung erhöht, da der Eingangsdruck und somit auch insgesamt der Druck der Dialysierlösung am Dialysator 200 erhöht ist. FIG. 3a shows a possible starting position in which all valves V1-V4 are closed, in which both chambers K1 and K2 are filled with dialysis solution or liquid and in which the membrane 161 is in a starting position. If, as shown in FIG. 3b, the valves V1 and V2 are opened, the membrane 161 can be pressed into the chamber K2 by the pressure in the chamber K1, which is higher than the pressure in the chamber K2, when the pressure builds up accordingly. In this case, dialysis solution is displaced from the chamber K2 in the direction of the feed line 110 and the dialysate flow is increased. Thus, in this constellation, the proportion of backward filtration in the dialyzer 200 is also increased compared to the starting position, since the inlet pressure and thus also the overall pressure of the dialysis solution at the dialyzer 200 is increased.
Ist die Membran 161 so weit in die Kammer K2 gedrückt, dass die Kammer K1 im Wesentlichen das gesamte Volumen der Bilanzkammer 160 ausfüllt, sinkt der Druck am Abzweigungspunkt des Anschlusses A2 wieder auf den nominellen Druck und der zusätzliche Dialysatfluss zum Dialysator 200 stoppt. Dies ist in Figur 3c gezeigt. If the membrane 161 is pressed so far into the chamber K2 that the chamber K1 essentially fills the entire volume of the balancing chamber 160, the pressure at the junction point of the connection A2 drops back to the nominal pressure and the additional dialysate flow to the dialyzer 200 stops. This is shown in Figure 3c.
Werden nun, wie in Figur 3d gezeigt, die Ventile V1 und V2 geschlossen und statt- dessen die Ventile V3 und V4 geöffnet, so wird die Membran 161 bei entsprechen dem Saugbetrieb der Pumpe 180 durch den im Verhältnis zum Druck in der Kam mer K1 höheren Druck in der Kammer K2 in die Kammer K1 zurück gedrückt. Da bei wird die Kammer K2 mit gebrauchter Dialysierlösung gefüllt, während die Flüs sigkeit aus der Kammer K1 in Richtung des Vorratsbehälters 181 verdrängt wird. Somit wird in dieser Konstellation der Anteil der Vorwärtsfiltration im Dialysator 200 gegenüber der Ausgangsstellung erhöht, da der Ausgangsdruck und somit auch insgesamt der Druck der Dialysierlösung am Dialysator 200 verringert ist. If now, as shown in FIG. 3d, the valves V1 and V2 are closed and instead the valves V3 and V4 are opened, the membrane 161 becomes higher in relation to the pressure in the chamber K1 during the suction operation of the pump 180 Pressure in chamber K2 pushed back into chamber K1. Since the chamber K2 is filled with used dialysis solution, while the liq fluid is displaced from the chamber K1 in the direction of the reservoir 181. Thus, in this constellation, the proportion of forward filtration in the dialyzer 200 is increased compared to the initial position, since the initial pressure and thus also the overall pressure of the dialysis solution at the dialyzer 200 is reduced.
Ist die Membran 161 so weit in die Kammer K1 gedrückt, dass die Kammer K2 im Wesentlichen das gesamte Volumen der Bilanzkammer 160 ausfüllt, steigt der Druck am Abzweigungspunkt des Anschlusses A3 wieder auf den nominellen Druck und der zusätzliche Dialysatfluss vom Dialysator 200 weg stoppt. Dies ist in Figur 3e gezeigt. Werden letztlich die Ventile V3 und V4 wieder geschlossen und stattdessen die Ventile V1 und V2 wieder geöffnet und die Pumpe 170 wieder betrieben, wie in Fi gur 3f gezeigt, so wird die Membran 161 wieder in die Kammer K2 gedrückt. If the membrane 161 is pressed so far into the chamber K1 that the chamber K2 essentially fills the entire volume of the balance chamber 160, the pressure at the junction point of the connection A3 rises again to the nominal pressure and the additional dialysate flow away from the dialyzer 200 stops. This is shown in Figure 3e. If finally the valves V3 and V4 are closed again and instead the valves V1 and V2 are opened again and the pump 170 is operated again, as shown in FIG. 3f, the membrane 161 is pressed again into the chamber K2.
Dabei wird die gebrauchte Dialysierlösung aus der Kammer K2 in Richtung der Zu leitung 110 verdrängt, womit die erfindungsgemäße Verfahrensführung nicht nur einen Push-Pull-Effekt erreicht, sondern auch dazu führt, dass ein Teil der ver brauchten Dialysierlösung wiederverwendet wird. The used dialysis solution is displaced from the chamber K2 in the direction of the supply line 110, so that the process according to the invention not only achieves a push-pull effect, but also means that part of the used dialysis solution is reused.
Dieser Effekt zeigt insbesondere am Ende einer Dialysebehandlung Vorteile, da zu diesem Zeitpunkt nur eine geringe Belastung des gebrauchten Dialysates mit Ur- ämtoxinen vorliegt. Dementsprechend ist es bevorzugt, dass eine erste Behand lungsperiode ohne Push- Pull- Betrieb und eine zweite Behandlungsperiode mit Push- Pull- Betrieb vorgesehen ist. This effect shows advantages, especially at the end of a dialysis treatment, since at this point in time the used dialysate is only slightly exposed to urine toxins. Accordingly, it is preferred that a first treatment period without push-pull operation and a second treatment period with push-pull operation are provided.
Eine Variante der in Figuren 1-3 dargestellten Ausführungsform ist in Figur 4 dar gestellt. In dieser Variante fehlt es an dem Anschluss A4, der Ventil V4, der Pumpe 180 und dem Reservoir 181. Stattdessen ist die Pumpe 170 als bidirektionale Pum pe ausgebildet, mit welcher der Druck in der Kammer K1 erhöht und erniedrigt wer den soll. Jede oben für die Ausführungsvariante gemäß Figuren 1-3 beschriebene Öffnung des Ventils V4 bei Betrieb der Pumpe 180 wird in dieser Ausführungsvari ante also jeweils durch eine Öffnung des Ventils V1 und einen Saugbetrieb der Pumpe 170 ersetzt. A variant of the embodiment shown in FIGS. 1-3 is shown in FIG. In this variant, the connection A4, the valve V4, the pump 180 and the reservoir 181 are absent. Instead, the pump 170 is designed as a bidirectional pump with which the pressure in the chamber K1 is to be increased and decreased. Each opening of the valve V4 described above for the embodiment variant according to FIGS. 1-3 when the pump 180 is in operation is thus replaced in this embodiment variant by an opening of the valve V1 and a suction operation of the pump 170.

Claims

Ansprüche Expectations
1. Dialysemaschine mit einem Fluidsystem, das eine Zuleitung zur Bereitstel lung von frischer Dialysierlösung an einen Dialysator und eine Ableitung zur Entfernung von verbrauchter Dialysierlösung aus dem Dialysator aufweist, wobei das Fluidsystem ein zwischen Zu- und Ableitung angeordnetes Bilan ziersystem aufweist, um die durch die Leitungen fließenden Flüssigkeitsvo lumina abzugleichen, und wobei das Fluidsystem eine zwischen dem Dialy sator und dem Bilanziersystem von der Ableitung abzweigende Ultrafiltrati onsleitung mit einer Ultrafiltrationspumpe aufweist, um dem Abgleich ein de finiertes Volumen an verbrauchter Dialysierlösung entziehen zu können, dadurch gekennzeichnet, dass eine zusätzliche Bilanzkammer vorgesehen ist, welche in einem zwi schen dem Bilanziersystem und dem Dialysator liegenden Abschnitt der Zu- leitung bzw. einem zwischen dem Dialysator und der Abzweigung der Ultra filtrationsleitung liegenden Abschnitt der Ableitung angeordnet ist. 1. Dialysis machine with a fluid system which has a supply line for the provision of fresh dialysis solution to a dialyzer and a discharge line for removing used dialysis solution from the dialyzer, the fluid system having a bilan system arranged between supply and discharge line to which the Lines to balance flowing liquid volumes, and wherein the fluid system has an ultrafiltration line with an ultrafiltration pump branching off between the dialyzer and the balancing system with an ultrafiltration pump in order to be able to withdraw a defined volume of used dialysis solution from the balancing, characterized in that an additional balancing chamber is provided, which is located between the balancing system and the dialyzer section of the supply line or a lying between the dialyzer and the branch of the ultrafiltration line section of the discharge line is arranged.
2. Dialysemaschine nach Anspruch 1, dadurch gekennzeichnet, dass die zu sätzliche Bilanzkammer ein vorzugsweise volumenstarres Behältnis auf weist, das anhand einer vorzugsweise elastischen Membran in zwei Kam mern unterteilt ist, wobei an einer ersten der Kammern ein Anschluss zur Verbindung der ersten Kammer mit der Zuleitung und ein Anschluss zur Ver bindung der ersten Kammer mit der Ableitung vorgesehen ist und wobei an beiden Anschlüssen ein Ventil zum Öffnen und Schließen des jeweiligen An schlusses angeordnet ist. 2. Dialysis machine according to claim 1, characterized in that the additional balance chamber has a preferably volume-rigid container, which is divided into two chambers by means of a preferably elastic membrane, with a connection on a first of the chambers for connecting the first chamber to the Supply line and a connection for connecting the first chamber to the discharge line are provided and a valve for opening and closing the respective connection is arranged on both connections.
3. Dialysemaschine nach Anspruch 2, dadurch gekennzeichnet, dass an der anderen der Kammern, also der zweiten Kammer wenigstens ein Anschluss zur Verbindung der zweiten Kammer mit einer Flüssigkeitssteuerpumpe vor gesehen ist, mit welcher der Druck in der zweiten Kammer erhöht oder er niedrigt werden kann, wobei der Anschluss vorzugsweise ein Ventil zu des sen Öffnen und Schließen aufweist. 3. Dialysis machine according to claim 2, characterized in that at least one connection for connecting the second chamber to a fluid control pump is seen on the other of the chambers, ie the second chamber, with which the pressure in the second chamber can be increased or decreased , wherein the connection preferably has a valve for opening and closing the sen.
4. Dialysemaschine nach Anspruch 3, dadurch gekennzeichnet, dass die Flüs sigkeitssteuerpumpe so ausgebildet ist, dass sie Flüssigkeiten in zwei Rich tungen fördern kann. 4. Dialysis machine according to claim 3, characterized in that the liquid control pump is designed so that it can convey liquids in two directions.
5. Dialysemaschine nach Anspruch 3, dadurch gekennzeichnet, dass an der zweiten Kammer zwei Anschlüsse zur Verbindung der zweiten Kammer mit jeweils einer Flüssigkeitssteuerpumpe vorgesehen sind, wobei anhand der Flüssigkeitssteuerpumpen der Druck in der zweiten Kammer erhöht oder er niedrigt werden kann. 5. Dialysis machine according to claim 3, characterized in that two connections are provided on the second chamber for connecting the second chamber, each with a fluid control pump, wherein the pressure in the second chamber can be increased or decreased using the fluid control pumps.
6. Dialysemaschine nach Anspruch 5, dadurch gekennzeichnet, dass eine der Flüssigkeitssteuerpumpen so ausgebildet ist, dass sie Flüssigkeiten in die zweite Kammer fördern kann, und dass die andere der Flüssigkeitssteuer- pumpen so ausgebildet ist, dass sie Flüssigkeiten aus der zweiten Kammer ziehen kann. 6. Dialysis machine according to claim 5, characterized in that one of the fluid control pumps is designed so that it can deliver fluids into the second chamber, and that the other of the fluid control pumps is designed so that they can draw liquids from the second chamber.
7. Dialysemaschine nach einem der Ansprüche 3 bis 6, dadurch gekennzeich net, dass die Dialysemaschine eine Steuereinheit aufweist, die mit den Venti len der zusätzlichen Bilanzkammer und der oder den Flüssigkeitssteuerpum pen in Signalverbindung steht und ausgebildet ist, die Ventile und Pumpen so anzusteuern, dass der Druck der Dialysierlösung im Dialysator durch ab wechselnde Befüllung und Entleerung der einen Kammer der zusätzlichen Bilanzkammer mit Dialysierlösung aus Zu- und Ableitung periodisch angeho ben und abgesenkt wird. 7. Dialysis machine according to one of claims 3 to 6, characterized in that the dialysis machine has a control unit which is in signal connection with the valves of the additional balance chamber and the liquid control pump or pumps and is designed to control the valves and pumps so that the pressure of the dialysis solution in the dialyzer is periodically raised and lowered by alternating filling and emptying of one chamber of the additional balance chamber with dialysis solution from the supply and discharge lines.
8. Dialysemaschine nach Anspruch 7, dadurch gekennzeichnet, dass die Steu ereinheit ausgebildet ist, in einer Behandlungsphase das die erste Kammer mit der Zuleitung verbindende Ventil zu öffnen, das die erste Kammer mit der Ableitung verbindende Ventil zu schließen und die Flüssigkeitssteuerpum- pe(n) zur Druckerhöhung in der zweiten Kammer zu aktivieren, um den Ein gangsdruck der Dialysierlösung am Dialysator zu erhöhen. 8. Dialysis machine according to claim 7, characterized in that the control unit is designed to open the valve connecting the first chamber to the supply line in a treatment phase, to close the valve connecting the first chamber to the discharge line and to close the liquid control pump (n ) to activate the pressure increase in the second chamber in order to increase the input pressure of the dialysis solution on the dialyzer.
9. Dialysemaschine nach Anspruch 7 oder 8, dadurch gekennzeichnet, dass die Steuereinheit ausgebildet ist, in einer Behandlungsphase das die erste Kammer mit der Ableitung verbindende Ventil zu öffnen, das die erste Kam mer mit der Zuleitung verbindende Ventile zu schließen und die Flüssigkeits- steuerpumpe(n) zur Druckverringerung in der zweiten Kammer zu aktivieren, um den Ausgangsdruck der Dialysierlösung am Dialysator zu verringern. 9. Dialysis machine according to claim 7 or 8, characterized in that the control unit is designed, in a treatment phase, to open the valve connecting the first chamber to the discharge line, to close the valves connecting the first chamber to the supply line and to close the fluid control pump (n) to activate the pressure reduction in the second chamber in order to reduce the outlet pressure of the dialysis solution at the dialyzer.
10. Dialysemaschine nach einem der vorhergehenden Ansprüche, dadurch ge kennzeichnet, dass das Fluidsystem einen zwischen dem Dialysator und dem Bilanziersystem in der Ableitung angeordneten Luftabscheider aufweist und dass die zusätzliche Bilanzkammer zwischen dem Bilanziersystem und dem Dialysator liegenden Abschnitt der Zuleitung und einem zwischen dem Dialysator und dem Luftabscheider liegenden Abschnitt der Ableitung ange ordnet ist. 10. Dialysis machine according to one of the preceding claims, characterized in that the fluid system has an air separator arranged between the dialyzer and the balancing system in the discharge line and that the additional balancing chamber between the balancing system and the dialyzer lying section of the supply line and one between the Dialyzer and the air separator lying section of the discharge is arranged.
11. Dialysemaschine nach einem der vorhergehenden Ansprüche, dadurch ge kennzeichnet, dass es sich bei der Bilanzierungsvorrichtung um ein Bilanz kammersystem mit zwei Bilanzkammern handelt. 11. Dialysis machine according to one of the preceding claims, characterized in that the balancing device is a balance chamber system with two balance chambers.
12. Dialysemaschine nach einem der vorhergehenden Ansprüche, dadurch ge kennzeichnet, dass es sich bei der Dialysemaschine um eine Dialysema schine zur Durchführung einer Hämodialysebehandlung handelt. 12. Dialysis machine according to one of the preceding claims, characterized in that the dialysis machine is a Dialysema machine for carrying out a hemodialysis treatment.
13. Verfahren zur Behandlung eines Dialysepatienten unter Verwendung einer Dialysemaschine nach einem der Ansprüche 1 bis 12, wobei eine erste Be handlungsperiode ohne Push- Pull- Betrieb und eine zweite Behandlungspe riode mit Push- Pull- Betrieb vorgesehen ist. 13. A method for treating a dialysis patient using a dialysis machine according to one of claims 1 to 12, wherein a first treatment period without push-pull operation and a second treatment period with push-pull operation is provided.
EP20804524.5A 2019-11-11 2020-11-10 Dialysis machine for carrying out a push/pull-based dialysis treatment Pending EP4058090A1 (en)

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DE102019130294.3A DE102019130294A1 (en) 2019-11-11 2019-11-11 Dialysis machine for carrying out a push-pull dialysis treatment
PCT/EP2020/081654 WO2021094317A1 (en) 2019-11-11 2020-11-10 Dialysis machine for carrying out a push/pull-based dialysis treatment

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EP (1) EP4058090A1 (en)
CN (1) CN114728113A (en)
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DE102014109639A1 (en) * 2014-07-09 2016-01-14 B. Braun Avitum Ag Valve for a dialysis machine and dialysis machine

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US11931494B2 (en) 2024-03-19
CN114728113A (en) 2022-07-08
DE102019130294A1 (en) 2021-05-12
US20220387683A1 (en) 2022-12-08

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