# US 10,369,261 B2 · Method and device for supplying dialysis liquid to a dialysis apparatus

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- Number: US 10,369,261 B2
- Document ID: US10369261B2
- Status: Granted
- Kind: B2
- Application number: 15/521,307
- Filed: 2015-10-14
- Published: 2017-10-26
- Granted: 2019-08-06
- Earliest claimed: 2014-10-25
- Assignees: Fresenius Medical Care Deutschland GmbH
- Applicants: Fresenius Medical Care Deutschland GmbH
- Inventors: Jorg Jonas; Wolfgang Wehmeyer
- Web page: https://patentgrep.com/patent/US10369261B2

## CPC

- A61M 1/1656: {Apparatus for preparing dialysates}
- A61M 1/14: Dialysis systems; Artificial kidneys; Blood oxygenators (semi-permeable membranes characterised by the material, manufacturing processes therefor B01D71/00){; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis}
- A61M 1/1601: {Control or regulation}
- A61M 1/1607: {before use, i.e. upstream of dialyser}
- A61M 1/1613: {Profiling or modelling of patient or predicted treatment evolution or outcome}
- A61M 1/1666: {by dissolving solids}
- A61M 1/1668: {Details of containers}
- A61M 1/167: {Flexible packaging for solid concentrates}
- A61M 2205/18: with alarm
- A61M 2205/3379: Masses, volumes, levels of fluids in reservoirs, flow rates
- A61M 2205/50: with microprocessors or computers
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

The invention relates to a method and to a device for supplying a dialysis device with dialysate, and to a dialysis device comprising a device for supplying the dialysis device with dialysate. For producing dialysate, a container 13 filled with a pulverulent dialysate concentrate K is provided, the amount of dialysate concentrate in the container being set in such a way that an amount of dialysate sufficient for a specified number of dialysis treatments can be produced using the dialysate concentrate. The method according to the invention and the device according to the invention make it possible to align the amount K2 of concentrate in the container 13 and the planned consumption amount, which is dependent on the prescription from the doctor and the treatment parameters established by the machine. After the individual dialysis treatments have been carried out, it is continuously monitored whether the amount of concentrate is sufficient. It may be monitored whether the amount of concentrate is sufficient for the following treatment or for all treatments still to be carried out. If it is not sufficient, an alarm signal is generated. Otherwise, a control signal for initiating each of the next treatment cycles is generated.

## Claims

### Claim 1

Method for supplying a dialysis device with dialysate, comprising the following method steps:
providing a container (13) that is intended for single use and is filled with a dialysate concentrate (K2) for producing dialysate, wherein the amount (M0) of dialysate concentrate in the container is set in such a way that it is possible to use the dialysate concentrate to produce an amount of dialysate sufficient for a specified number (x) of treatment cycles,
inputting treatment parameters for each treatment cycle of the predetermined number (x) of treatment cycles using an input unit (24A),
determining a provided amount (V1, V2, V3, . . . Vx) of dialysate concentrate for each treatment cycle of the specified number (x) of treatment cycles on the basis of the inputted treatment parameters using an arithmetic and evaluation unit (24),
calculating the difference in the amount (M0) of dialysate concentrate in the container and the amount (V1+V2+V3 . . . +Vx) of dialysate concentrate provided for the specified number (x) of treatment cycles, wherein
an alarm signal for generating an alarm is generated if the amount (M0) of dialysate concentrate in the container is less than the amount (V1+V2+V3 . . . +Vx) of dialysate concentrate provided for the specified number (x) of treatment cycles, and
a control signal for initiating the first treatment cycle is generated if the amount (M0) of dialysate concentrate in the container is not less than the amount of dialysate concentrate provided for the specified number (x) of treatment cycles (V1+V2+V3 . . . +Vx).

### Claim 2 (depends on 1)

Method for supplying a dialysis device according to claim 1, characterised in that, after the first treatment has been carried out using the amount (V1) of dialysate concentrate provided for the first treatment cycle and before the start of each subsequent treatment cycle using the amount (V1, V2, V3, . . . Vx) of dialysate concentrate provided for the relevant subsequent treatment cycle,
the amount (Vactual) of dialysate concentrate actually used up in the preceding treatment cycle is determined,
the residual volume of dialysate concentrate available for the treatment cycles still to be carried out is calculated from the difference between the amount of dialysate concentrate in the container before the preceding treatment was carried out and the amount of dialysate concentrate actually used up in the preceding treatment cycle, and
an alarm signal for an alarm is generated if the residual amount of dialysate concentrate is less than the amount of dialysate concentrate provided for the treatment cycles still to be carried out, and
a control signal for initiating the following dialysis treatment is generated if the residual amount of dialysate concentrate is not less than the amount of dialysate concentrate provided for the treatment cycles still to be carried out.

### Claim 3 (depends on 1)

Method for supplying a dialysis device according to claim 1, characterised in that, after the first treatment cycle has been carried out using the amount (V1) of dialysate concentrate provided for the first treatment cycle and before the start of each subsequent treatment cycle using the amount (V1, V2, V3, . . . Vx) of dialysate concentrate provided for each of the subsequent treatment cycles,
the amount (Vactual) of dialysate concentrate actually used up in the preceding treatment cycle is determined,
the residual volume of dialysate concentrate available for the treatment cycles still to be carried out is calculated from the difference between the amount of dialysate concentrate in the container before the preceding treatment cycle was carried out and the amount of dialysate concentrate actually used up in the preceding treatment cycle, and
an alarm signal for an alarm is generated if the residual amount of dialysate concentrate is less than the amount of dialysate concentrate provided for the following treatment cycle, and
a control signal for initiating the following dialysis treatment is generated if the residual amount of dialysate concentrate is not less than the amount of dialysate concentrate provided for the following treatment cycle.

### Claim 4 (depends on 2)

Method for supplying a dialysis device according to claim 2, characterised in that, if the residual amount of dialysate concentrate is greater than the amount of dialysate concentrate provided for the final treatment cycle, the dialysis device is controlled in such a way that the residual amount of dialysate concentrate is used up in the final treatment cycle or a predetermined residual amount of dialysate concentrate remains in the container.

### Claim 5 (depends on 1)

Method for supplying a dialysis device according to claim 1, characterised in that, before the treatment cycles are carried out, the amount (M0) of dialysate concentrate in the container is subdivided among the specified number (x) of treatment cycles, the treatment cycles each being allocated a specified amount (V1′, V2′, V3′ . . . Vx′) of dialysate concentrate that is set in such a way that, after the treatment cycles have been carried out, a specified residual amount or no residual amount of dialysate concentrate remains in the container.

### Claim 6 (depends on 5)

Method for supplying a dialysis device according to claim 5, characterised in that the dialysis device is controlled in such a way that the amount (V1′) of dialysate concentrate specified for the first treatment cycle is used up.

### Claim 7 (depends on 6)

Method for supplying a dialysis device according to claim 6, characterised in that, after the first treatment cycle has been carried out using the amount (V1′) of dialysate concentrate specified for the first treatment cycle and before the start of each subsequent treatment cycle using the amount of dialysate concentrate specified for the relevant subsequent treatment cycle,
the amount (Vactual) of dialysate concentrate actually used up in the preceding treatment cycle is determined,
the residual volume of dialysate concentrate available for the treatment cycles still to be carried out is calculated from the difference between the amount of dialysate concentrate in the container before the preceding treatment cycle was carried out and the amount of dialysate concentrate actually used up in the preceding treatment cycle, and
the residual volume of dialysate concentrate available for each of the treatment cycles still to be carried out is subdivided among the number of treatment cycles still to be carried out, the treatment cycles each being allocated a specified amount (V1″, V2″, V3″ . . . Vx″) of dialysate concentrate that is set in such a way that, after the treatment cycles have been carried out, a specified residual amount or no residual amount of dialysate concentrate remains in the container.

### Claim 8 (depends on 7)

Method for supplying a dialysis device according to claim 7, characterised in that an alarm signal for generating an alarm is generated if the residual volume of dialysate concentrate available for each of the treatment cycles still to be carried out is less than the amount of dialysate concentrate specified for the treatment cycles still to be carried out, and
a control signal for initiating the following treatment cycle is generated if the residual volume of dialysate concentrate available for each of the treatment cycles still to be carried out is not less than the amount of dialysate concentrate specified for the treatment cycles still to be carried out.

### Claim 9 (depends on 1)

Method for supplying a dialysis device according to claim 1, characterised in that the treatment cycle comprises a preparation phase, preceding the dialysis treatment, for preparing the dialysis treatment and a treatment phase for carrying out the dialysis treatment, the amount of dialysate concentrate provided for a treatment cycle comprising a specified amount of dialysate concentrate for the preparation phase and a specified amount of dialysate concentrate for the treatment phase.

### Claim 10

Device for supplying a dialysis device with dialysate, comprising
a connecting unit (50) for connecting a container (13) that is intended for single use and is filled with a dialysate concentrate (K2) for producing dialysate, wherein the amount (M0) of dialysate concentrate in the container is set in such a way that it is possible to use the dialysate concentrate to produce an amount of dialysate sufficient for a specified number (x) of treatment cycles can be,
an input unit (24A) for inputting treatment parameters for each treatment cycle of the specified number (x) of treatment cycles,
an arithmetic and evaluation unit (24), configured in such a way that
an amount (V1, V2, V3, . . . Vx) of dialysate concentrate provided for the treatment cycle is determined for each treatment cycle of the specified number (x) of treatment cycles on the basis of the inputted treatment parameters,
the difference between the amount (M0) of dialysate concentrate in the container and the amount (V1+V2+V3 . . . +Vx) of dialysate concentrate provided for the specified number (x) of treatment cycles is calculated, wherein
an alarm signal for generating an alarm is generated if the amount (M0) of dialysate concentrate in the container is less than the amount (V1+V2+V3 . . . +Vx) of dialysate concentrate provided for the specified number of treatment cycles, and
a control signal for initiating the first treatment cycle is generated if the amount (M0) of dialysate concentrate in the container is not less than the amount (V1+V2+V3 . . . +Vx) of dialysate concentrate provided for the specified number of treatment cycles.

### Claim 11 (depends on 10)

Device for supplying a dialysis device with dialysate according to claim 10, characterised in that the arithmetic and evaluation unit (24) is configured in such a way that
after the first treatment cycle has been carried out using the amount of dialysate concentrate provided for the first treatment cycle and before the start of each subsequent treatment cycle using the amount of dialysate concentrate provided for each of the subsequent treatment cycles,
the amount (Vactual) of dialysate concentrate actually used up in the preceding treatment cycle is determined,
the residual volume of dialysate concentrate available for the treatment cycles still to be carried out is calculated from the difference between the amount of dialysate concentrate in the container before the preceding treatment cycle was carried out and the amount of dialysate concentrate actually used up in the preceding treatment cycle, and
an alarm signal for an alarm is generated if the residual amount of dialysate concentrate is less than the amount of dialysate concentrate provided for the treatment cycles still to be carried out, and
a control signal for initiating the following dialysis treatment is generated if the residual amount of dialysate concentrate is not less than the amount of dialysate concentrate provided for the treatment cycles still to be carried out.

### Claim 12 (depends on 10)

Device for supplying a dialysis device with dialysate according to claim 10, characterised in that the arithmetic and evaluation unit (24) is configured in such a way that
after the first treatment cycle has been carried out and before the start of each subsequent treatment cycle,
the amount (Vactual) of dialysate concentrate actually used up in the preceding treatment cycle is determined,
the residual volume of dialysate concentrate available for the treatment cycles still to be carried out is calculated from the difference between the amount of dialysate concentrate in the container before the preceding treatment cycle was carried out and the amount of dialysate concentrate actually used up in the preceding treatment cycle, and
an alarm signal for an alarm is generated if the residual amount of dialysate concentrate is less than the amount of dialysate concentrate provided for the following treatment cycle, and
a control signal for initiating the following dialysis treatment is generated if the residual amount of dialysate concentrate is not less than the amount of dialysate concentrate provided for the following treatment cycle.

### Claim 13 (depends on 11)

Device for supplying a dialysis device with dialysate according to claim 11, characterised in that the arithmetic and evaluation unit (24) is configured in such a way that
if the residual amount of dialysate concentrate is greater than the amount of dialysate concentrate provided for the final treatment cycle, a control signal is generated for the dialysis device, by means of which signal the dialysis device is controlled in such a way that the residual amount of dialysate concentrate is completely used up in the final treatment cycle or a specified residual amount of dialysate concentrate remains in the container.

### Claim 14 (depends on 10)

Device for supplying a dialysis device with dialysate according to claim 10, characterised in that the arithmetic and evaluation unit (24) is configured in such a way that before the treatment cycles are carried out, the amount (M0) of dialysate concentrate in the container is subdivided among the specified number x of treatment cycles, the treatment cycles each being allocated a specified amount (V1′, V2′, V3′ . . . Vx′) of dialysate concentrate that is set in such a way that, after the treatment cycles have been carried out, a specified residual amount or no residual amount of dialysate concentrate remains in the container.

### Claim 15 (depends on 14)

Device for supplying a dialysis device with dialysate according to claim 14, characterised in that the arithmetic and evaluation unit (24) is configured in such a way that a control signal is generated for the dialysis device, by means of which signal the dialysis device is controlled in such a way that the amount (V1′) of dialysate concentrate specified for the first treatment cycle is used up.

### Claim 16 (depends on 15)

Device for supplying a dialysis device with dialysate according to claim 15, characterised in that the arithmetic and evaluation unit (24) is configured in such a way that after the first treatment cycle has been carried out using the amount of dialysate concentrate specified for the first treatment cycle and before the start of each subsequent treatment cycle using the amount of dialysate concentrate specified for each of the subsequent treatment cycles, the amount (Vactual) of dialysate concentrate actually used up in the preceding treatment cycle is determined,
the residual volume of dialysate concentrate available for the treatment cycles still to be carried out is calculated from the difference between the amount of dialysate concentrate in the container before the preceding treatment cycle was carried out and the amount of dialysate concentrate actually used up in the preceding treatment cycle, and
the residual volume of dialysate concentrate available for each of the treatment cycles still to be carried out is subdivided among the number of treatment cycles still to be carried out, the treatment cycles each being allocated a specified amount V1″, V2″, V3″ . . . Vx″ of dialysate concentrate that is set in such a way that, after the treatment cycles have been carried out, a specified residual amount or no residual amount of dialysate concentrate remains in the container.

### Claim 17 (depends on 16)

Device for supplying a dialysis device with dialysate according to claim 16, characterised in that the arithmetic and evaluation unit (24) is configured in such a way that an alarm signal for generating an alarm is generated if the residual volume of dialysate concentrate available for each of the treatment cycles still to be carried out is less than the amount of dialysate concentrate specified for the treatment cycles still to be carried out, and
a control signal for initiating the following treatment cycle is generated if the residual volume of dialysate concentrate available for each of the treatment cycles still to be carried out is not less than the amount of dialysate concentrate specified for the treatment cycles still to be carried out.

### Claim 18 (depends on 10)

Device for supplying a dialysis device with dialysate according to claim 10, characterised in that the treatment cycle comprises a preparation phase, preceding the dialysis treatment, for preparing the dialysis treatment and a treatment phase for carrying out the dialysis treatment, the amount of dialysate concentrate provided for one treatment cycle comprising a specified amount of dialysate concentrate for the preparation phase and a specified amount of dialysate concentrate for the treatment phase.

### Claim 19 (depends on 10)

Device for supplying a dialysis device with dialysate according to claim 10, characterised in that the container is a bag or cartridge, the volume of the bag or cartridge being set in such a way that the bag or cartridge holds an amount of dialysate concentrate sufficient for a specified number (x) of treatment cycles.

### Claim 20 (depends on 10)

Dialysis device comprising a device for supplying the dialysis device with dialysate according to claim 10.
