EP4058090A1 - Machine de dialyse pour réaliser un traitement de dialyse push-pull - Google Patents
Machine de dialyse pour réaliser un traitement de dialyse push-pullInfo
- 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
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.
Landscapes
- Health & Medical Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Engineering & Computer Science (AREA)
- Anesthesiology (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)
- Urology & Nephrology (AREA)
- Emergency Medicine (AREA)
- External Artificial Organs (AREA)
Abstract
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE102019130294.3A DE102019130294A1 (de) | 2019-11-11 | 2019-11-11 | Dialysemaschine zur Durchführung einer Push-Pull-Dialysebehandlung |
| PCT/EP2020/081654 WO2021094317A1 (fr) | 2019-11-11 | 2020-11-10 | Machine de dialyse pour réaliser un traitement de dialyse push-pull |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| EP4058090A1 true EP4058090A1 (fr) | 2022-09-21 |
Family
ID=73344059
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EP20804524.5A Pending EP4058090A1 (fr) | 2019-11-11 | 2020-11-10 | Machine de dialyse pour réaliser un traitement de dialyse push-pull |
Country Status (5)
| Country | Link |
|---|---|
| US (1) | US11931494B2 (fr) |
| EP (1) | EP4058090A1 (fr) |
| CN (1) | CN114728113A (fr) |
| DE (1) | DE102019130294A1 (fr) |
| WO (1) | WO2021094317A1 (fr) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE102019118521A1 (de) * | 2019-07-09 | 2021-01-14 | Fresenius Medical Care Deutschland Gmbh | Dialysegerät und Verfahren zum Betreiben eines Bilanzkammersystems eines Dialysegerätes |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20090008306A1 (en) * | 2007-07-05 | 2009-01-08 | Baxter International Inc. | Extracorporeal dialysis ready peritoneal dialysis machine |
Family Cites Families (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4079007A (en) * | 1976-09-07 | 1978-03-14 | Union Carbide Corporation | Hemodialysis system with modular dialysate manifold assembly |
| US4897184A (en) * | 1986-10-31 | 1990-01-30 | Cobe Laboratories, Inc. | Fluid flow apparatus control and monitoring |
| DE3837498A1 (de) | 1988-11-04 | 1990-05-17 | Fresenius Ag | Verfahren und vorrichtung zur ultrafiltration bei der haemodialyse |
| DE19708391C1 (de) * | 1997-03-01 | 1998-10-22 | Fresenius Medical Care De Gmbh | Verfahren und Vorrichtung zur Ultrafiltration bei der Hämodialyse |
| DE19830928C1 (de) | 1998-07-10 | 1999-05-06 | Fresenius Medical Care De Gmbh | Vorrichtung der Dialyse |
| DE102010023635A1 (de) * | 2010-06-14 | 2011-12-15 | Fresenius Medical Care Deutschland Gmbh | Vorrichtung und Verfahren zum Fördern von Flüssigkeiten in die Behandlungseinheit einer medizinischen Behandlungsvorrichtung, insbesondere in den Dialysator einer Dialysevorrichtung |
| DE102011106111B4 (de) * | 2011-06-09 | 2013-11-21 | Fresenius Medical Care Deutschland Gmbh | Verfahren und Vorrichiung zum Bestimmen mindestens eines vom Absolutdruck abhängigen Betriebsparameters einer Vorrichtung zur extrakorporalen Blutbehandlung, Vorrichtung zur extrakorporalen Blutbehandlung |
| DE102014109639A1 (de) * | 2014-07-09 | 2016-01-14 | B. Braun Avitum Ag | Ventil für ein Dialysegerät und Dialysegerät |
-
2019
- 2019-11-11 DE DE102019130294.3A patent/DE102019130294A1/de active Pending
-
2020
- 2020-11-10 EP EP20804524.5A patent/EP4058090A1/fr active Pending
- 2020-11-10 CN CN202080079641.4A patent/CN114728113A/zh active Pending
- 2020-11-10 WO PCT/EP2020/081654 patent/WO2021094317A1/fr not_active Ceased
- 2020-11-10 US US17/775,326 patent/US11931494B2/en active Active
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20090008306A1 (en) * | 2007-07-05 | 2009-01-08 | Baxter International Inc. | Extracorporeal dialysis ready peritoneal dialysis machine |
Also Published As
| Publication number | Publication date |
|---|---|
| DE102019130294A1 (de) | 2021-05-12 |
| US11931494B2 (en) | 2024-03-19 |
| CN114728113A (zh) | 2022-07-08 |
| US20220387683A1 (en) | 2022-12-08 |
| WO2021094317A1 (fr) | 2021-05-20 |
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