APPARATUS AND METHOD FOR PREPARING A DIALYSIS SOLUTION

Abstract

The present invention relates to a method and to an apparatus for preparing a dialysis solution, wherein the apparatus has a first circuit and a second circuit, wherein the first circuit has a container for receiving the consumed dialysis solution or fresh water or another fluid, the primary side of a filter connected downstream of the container, and a return line from the primary side of the filter into the container, wherein the filter is configured to prepare purified water from the consumed dialysis solution or from fresh water or from another fluid, and wherein the second circuit has the secondary side of the filter, the dialyzate side of a dialyzer, a reservoir, a line that leads from the reservoir to the secondary side of the filter, by means of which dialyzate or a dialyzate concentrate can be supplied to the secondary side of the filter, and a filtrate line that leads away from the secondary side of the filter.

Claims

1. An apparatus for preparing a dialysis solution, wherein the apparatus has a first circuit and a second circuit, wherein the first circuit has a container (10) for receiving the consumed dialysis solution or fresh water or another fluid, the primary side (21) of a filter (20) connected downstream of the container (10), and a return line (30) from the primary side (21) of the filter (20) into the container (10), wherein the filter (20) is configured to prepare purified water from the consumed dialysis solution or from fresh water or from another fluid, and wherein the second circuit has the secondary side (22) of the filter (20), the dialyzate side of a dialyzer (100), a reservoir (200), a line (K) that leads from the reservoir (200) to the secondary side (22) of the filter and by means of which dialyzate or a dialyzate concentrate can be supplied to the secondary side (22) of the filter (20), and a filtrate line (F) that leads away from the secondary side (22) of the filter (20).

2. An apparatus in accordance with claim 1, characterized in that a return line (40) from the dialyzate side of the dialyzer (100) into the container (10) is present; or in that a line (41′) is present from the dialyzate side of the dialyzer (100) into a drain.

3. An apparatus in accordance with claim 1, characterized in that the filter (20) is a graphene filter.

4. An apparatus in accordance with claim 1, characterized in that the filtrate line (F) leads from the secondary side (22) of the filter (20) to a balancing chamber (BK) of the apparatus and/or to the reservoir (200).

5. An apparatus in accordance with claim 1, characterized in that ready-to-use dialysis solution or a concentrate, in particular a bicarbonate concentrate, is present in the reservoir (200) that is used to prepare a ready-to-use dialysis solution.

6. An apparatus in accordance with claim 1, characterized in that the reservoir (200) is a dialyzate mixing device (200).

7. An apparatus in accordance with claim 1, characterized in that a pump (51) is arranged in the line (K) and is configured to supply a defined volume or a defined volume flow to the secondary side (22) of the filter (20).

8. An apparatus in accordance with claim 1, characterized in that a pump (50) is arranged in the first circuit, preferably upstream of the primary side (21) of the filter (20) to effect a flow of liquid in the first circuit; and/or in that a pressure relief device (60) by means of which pressure can be set on the primary side (21) of the filter (20) is provided in the first circuit, preferably downstream of the filter (20).

9. An apparatus in accordance with claim 1, characterized in that one or more sensors, preferably one or more conductivity measuring cells (L1, L3) are arranged in the first circuit and are arranged upstream and downstream of the primary side (21) of the filter (20); and/or characterized in that one or more sensors, preferably one or more conductivity measuring cells (L2, L4) are arranged in the second circuit in the line (K) and/or in the filtrate line (F).

10. An apparatus in accordance with claim 1, characterized in that one or more pressure measuring devices (S1, S2) are arranged downstream of the secondary side (22) of the filter (20) and/or upstream of the primary side (21) of the filter (20).

11. An apparatus in accordance with claim 1, characterized in that the apparatus has an ultrafiltrate pump for removing dialysis solution, preferably from the return line (40) from the dialyzer (100) to the container (10) and/or has a balancing chamber (B) for the balanced supply and removal of dialysis solution to and from the dialyzer (100).

12. An apparatus in accordance with claim 1, characterized in that the filter (20) is impermeable to gas; and/or in that the second circuit does not have a degassing device.

13. An apparatus in accordance with claim 1, characterized in that the first and/or second circuits are closed or open.

14. An apparatus in accordance with claim 1, characterized in that the container (10) is configured as a rigid vessel or as a bag, in particular as a flexible bag, further in particular as a single-use (disposable) article; and/or characterized in that the apparatus forms a dialysis machine or a part of a dialysis machine.

15. A method of preparing a dialysis solution using an apparatus in accordance with claim 1, characterized in that the solution is supplied from the container (10) to the primary side (21) of the filter (20) and the retentate is returned into the container (10), with a dialysis solution or a dialysis concentrate being supplied to the secondary side (22) of the filter (20) that is mixed with the permeate of the filter (20) on its secondary side (22).

16. A method in accordance with claim 15, characterized in that the permeate is supplied together with the dialysis solution or the dialyzate concentrate to a reservoir (200) in which a ready-to-use dialysis solution is prepared that is supplied to a dialyzer (100).

17. A method in accordance with claim 16, characterized in that the mixing region (200) is formed by the reservoir (200).

18. A method in accordance with claim 15, characterized in that the dialyzate concentrate contains only one single conductive component apart from water.

19. A method in accordance with claim 15, characterized in that a pump (51) is arranged in the line (K) and supplies a defined volume or a defined volume flow of dialysis solution or of dialyzate concentrate to the secondary side (22) of the filter (20).

20. A method in accordance with claim 15, characterized in that permeate arising on the secondary side (22) of the filter (20) is conducted together with the supplied dialysis solution or dialyzate concentrate into a balancing chamber (BK).

21. A method in accordance with claim 15, characterized in that permeate arising on the secondary side (22) of the filter (20) is conducted together with the supplied dialysis solution or dialyzate concentrate into the reservoir (200) or into the mixing region (200).

Description

[0051] Further details and advantages of the invention will be explained in more detail with reference to an embodiment shown in the drawing.

[0052] There are shown:

[0053] FIG. 1: a schematic flowchart of an apparatus in accordance with the invention in a first embodiment of the invention;

[0054] FIG. 2: a schematic flowchart of an apparatus in accordance with the invention in a second embodiment of the invention;

[0055] FIG. 3: a schematic flowchart of an apparatus in accordance with the invention in a third embodiment of the invention;

[0056] FIG. 4: a schematic flowchart of an apparatus in accordance with the invention in a fourth embodiment of the invention; and

[0057] FIG. 5: a schematic flow diagram of a further apparatus that is not a subject of the invention.

[0058] As stated above, FIG. 5 shows a variant that is not the subject of the invention. Elements that are the same or are functionally the same in accordance with FIG. 5 have the same reference numerals as in FIGS. 1 to 4 so that reference is also made to FIG. 5 with respect to the structure of the apparatus shown in FIGS. 1 to 4.

[0059] As can be seen from FIG. 1, the apparatus shown in FIG. 1 essentially differs with respect to the arrangement in accordance with FIG. 5 in that a line K runs from the reservoir 200 to the secondary side 22 of the filter, through which line K the ready-to-use dialysis solution flows. The conductivity sensor L2 is located in this line K.

[0060] At the drain side, a filtrate line F leads from the secondary side 22 of the filter 20 to the reservoir 200. This line conducts a mixture of the dialyzate supplied over the line K with the ultrapure water acquired by means of the filter 20, e.g. by RO. The conductivity sensor L4 is located in the line F.

[0061] A line 52 is furthermore provided that can be closed by the valve V7 and by which the reservoir 200 is in fluid communication with the line through which fluid is supplied from the container to the primary side 21 of the filter 20. The pump 50 and the conductivity sensor L1 are located in the last-named line. The reservoir 200 is accordingly in fluid communication with the primary side 21 of the filter 20 with an open valve.

[0062] In an apparatus in accordance with FIG. 1, the mass transfer or the volume transition over the filter is measured and ensured by the conductivity sensors L2 and L4. FIG. 2 shows an embodiment in which a concentrate or a concentrate mixture, in particular a bicarbonate concentrate, is conveyed through the line K. The pump 51 located in the line K serves this purpose. A concentrated solution is thus conveyed to the secondary side 22 of the filter, with its conductivity being determined by the conductivity sensor L2. A certain, i.e. defined, volume of this concentrate or of the mixture is conveyed by means of the pump 51. This concentrate or mixture is mixed with ultrapure water in the filter 20, which ultrapure water dilutes the concentrate or the concentrate mixture on the secondary side.

[0063] The mixture is supplied to the balancing chamber BK that is designed with four valves and that has two chambers which are separated by a movable partition wall and of which each has an inflow valve and an outflow valve.

[0064] The balancing chamber BK thus receives the concentrate or concentrate mixture diluted with ultrapure water. A purely volume controlled mixing process thus results that can be monitored by an independent conductivity measurement (conductivity sensor L4). Only the concentrate contributes to the conductivity (in contrast to the embodiment in accordance with FIG. 1) as a component of the ready-to-use dialysis solution. An expected value for the conductivity can thus be calculated. The regulation to an expected value of a conductivity can be simply carried out.

[0065] It is also conceivable to provide a regulation or a feedback loop whose desired value is the volume of diluted concentrate/concentrate mixture supplied to the balancing chamber, with the actual value being provided by the conductivity measurement. The specific retention capability of the filter is decisive for this. With knowledge of the conductivity in the line K and with knowledge of the conductivity in the line F, a determination can be made as to by which amount the volume conveyed by the pump has increased due to the transfer of ultrapure water, i.e. which volume is supplied to the balancing chamber or to the reservoir 200 connected downstream of it.

[0066] As can further be seen from FIG. 2, the primary side 21 of the filter 20 or the lines leading off therefrom is in fluid communication with the reservoir 200 via the line 96 in which the valve V5 is located.

[0067] The embodiment in accordance with FIG. 3 differs from the variant in accordance with FIG. 2 by a total of four conductivity sensors L1-L4 of which two are arranged upstream and downstream of the primary side 21 of the filter and two are arranged in the concentrate line K and in the filtrate line F. With knowledge of the input conductivity and output conductivity, the process can additionally be verified, controlled, and monitored.

[0068] Pressure measurement sensors S1 and S2 are furthermore provided that serve the monitoring of the transmembrane pressure over the membrane of the filter 20. The sensor S1 is located at the inflow side on the primary side of the filter 20 and the sensor S2 is located in the filtrate line F. The values of the sensors can be used to be able to recognize a degradation of the filter F e.g. by scaling and to be able to plan and carry out flushing cycles/regeneration cycles of the filter.

[0069] It can additionally be recognized by means of the sensor S2 whether sufficient ultrapure water has flowed over the filter 20 onto its secondary side 22 and whether the balancing chamber is full so that the desired mixing relationship is reached and the balancing chamber can be switched over or cycled. A new “mixing cycle” can then be started by the pump 51.

[0070] Alternatively, the evaluation of the torque or of the motor current of the pump 51 can be used to reach the desired mixing ratio.

[0071] The value of the conductivity sensor L1 can be used to control the fresh water cycle, i.e. to recognize when the retentate in the container 10 has to be replaced by fresh water.

[0072] Not only the use of a filter 20 is generally covered by the invention, but rather also the use of a plurality of filters connected after one another, i.e. cascaded. This relieves the pump 50, but requires the presence of a plurality of pumps.

[0073] The chamber 10 can be designed as a rigid container or as a bag.

[0074] The filter 20 can be flushed and thus cleaned e.g. by opening the valves V3 and 90.

[0075] Alternatively, the secondary side can initially be filled with fresh water via the valve V5 or V6. A filling with fresh water via the filter 20 and the balancing chamber BK is, however, advantageous.

[0076] As can be seen from FIG. 4, the method can also be carried out without the return of consumed dialyzate into the container 10. In this case, the consumed dialyzate is discarded via the line 40′. A preheating of the water supplied to the container 10 by means of the consumed dialysis solution takes place via the heat exchanger WT.