# US 11,439,736 B2 · Dialysis system with online dialysis fluid generation

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- Number: US 11,439,736 B2
- Document ID: US11439736B2
- Status: Granted
- Kind: B2
- Application number: 16/385,162
- Filed: 2019-04-16
- Published: 2019-08-08
- Granted: 2022-09-13
- Earliest claimed: 2008-07-25
- Assignees: Baxter International Inc.; Baxter Healthcare S.A.
- Applicants: Baxter International Inc.; Baxter Healthcare SA
- Inventors: Justin B. Rohde; Shincy J. Maliekkal
- Web page: https://patentgrep.com/patent/US11439736B2

## CPC

- A61M 1/1656: {Apparatus for preparing dialysates}
- A61M 1/1635: {with volume chamber balancing devices between used and fresh dialysis fluid}
- 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

A dialysis system includes a dialysis machine including at least one pump positioned and arranged to pump a dialysis fluid; and a dialysis fluid source located separate from and in fluid communication with the dialysis fluid machine, the dialysis fluid source including a purified water line for carrying purified water, a source of a first concentrate, a source of a second concentrate, a first concentrate pump positioned and arranged to pump first concentrate from the first concentrate source, and a second concentrate pump positioned and arranged to pump second concentrate from the second concentrate source, wherein dialysis fluid is prepared for delivery from the dialysis fluid source to the dialysis machine by mixing the purified water with the first concentrate pumped by the first concentrate pump and the second concentrate pumped by the second concentrate pump.

## Claims

### Claim 1

A dialysis system comprising:
a dialysis machine including at least one pump positioned and arranged to pump a dialysis fluid;
a dialysis fluid source located separate from and in fluid communication with the dialysis machine, the dialysis fluid source including
a purified water line for carrying purified water,
a source of a first concentrate,
a source of a second concentrate,
a first concentrate pump positioned and arranged to pump the first concentrate from the first concentrate source, and
a second concentrate pump positioned and arranged to pump the second concentrate from the second concentrate source,
wherein the dialysis fluid is prepared for delivery from the dialysis fluid source to the dialysis machine by mixing the purified water with the first concentrate pumped by the first concentrate pump and the second concentrate pumped by the second concentrate pump; and
a flow regulation device located between the dialysis fluid source and the dialysis machine, the flow regulation device including an inlet in fluid communication with the dialysis fluid source, an outlet in fluid communication with the dialysis machine, and a closed volume defined by walls that are configured to expand and contract to provide a variable internal volume,
wherein a cross-sectional width of the variable internal volume of the flow regulation device is larger than diameters of the inlet and the outlet to smooth changes in a draw rate of the dialysis fluid from the dialysis machine.

### Claim 2 (depends on 1)

The dialysis system of claim 1, wherein the dialysis machine is a peritoneal dialysis machine, and wherein one of the first or second concentrates includes an osmotic agent.

### Claim 3 (depends on 1)

The dialysis system of claim 1, wherein the dialysis machine is a blood treatment machine, and wherein one of the first or second concentrates includes acid.

### Claim 4 (depends on 1)

The dialysis system of claim 1, wherein the dialysis fluid source further includes an air trap positioned and arranged to remove air from the purified water mixed with at least one of the first concentrate or the second concentrate.

### Claim 5 (depends on 1)

The dialysis system of claim 1, wherein the dialysis fluid source further includes a mixing chamber positioned and arranged to aid mixing of the purified water and at least one of the first or second concentrates.

### Claim 6 (depends on 5)

The dialysis system of claim 5, wherein the mixing chamber is a first mixing chamber positioned and arranged to aid mixing of the purified water and the first concentrate, and wherein the dialysis fluid source further includes a second mixing chamber positioned and arranged to aid mixing of the purified water, the first concentrate and the second concentrate.

### Claim 7 (depends on 1)

The dialysis system of claim 1, wherein the dialysis fluid source further includes a heater positioned and arranged to heat the purified water flowing through the purified water line.

### Claim 8 (depends on 1)

The dialysis system of claim 1, wherein the dialysis fluid source further includes a conductivity sensor positioned and arranged to sense the conductivity of the dialysis fluid prepared by mixing the purified water with the first concentrate and the second concentrate.

### Claim 9 (depends on 8)

The dialysis system of claim 8, wherein the conductivity sensor is a first conductivity sensor, and wherein the dialysis fluid source further includes a second conductivity sensor positioned and arranged to sense the conductivity of the purified water mixed with the first concentrate.

### Claim 10 (depends on 1)

The dialysis system of claim 1, wherein the dialysis fluid source further includes at least one filter configured to remove at least one of particles or endotoxin.

### Claim 11 (depends on 10)

The dialysis system of claim 10, wherein the at least one filter is positioned and arranged to filter the mixed dialysis fluid.

### Claim 12

A dialysis system comprising:
a dialysis machine including at least one pump positioned and arranged to pump a dialysis fluid;
a dialysis fluid source located separate from and in fluid communication with the dialysis machine, the dialysis fluid source including
a purified water line for carrying purified water,
a source of a first concentrate,
a source of a second concentrate, and
at least one filter configured to remove at least one of particles or endotoxin,
wherein the dialysis fluid is prepared for delivery from the dialysis fluid source to the dialysis machine by mixing the purified water with the first concentrate and the second concentrate; and
a flow regulation device located between the dialysis fluid source and the dialysis machine, the flow regulation device including an inlet in fluid communication with the dialysis fluid source, an outlet in fluid communication with the dialysis machine, and a closed volume defined by walls that are configured to expand and contract to provide a variable internal volume,
wherein a cross-sectional width of the variable internal volume of the flow regulation device is larger than diameters of the inlet and the outlet to smooth changes in a draw rate of the dialysis fluid from the dialysis machine.

### Claim 13 (depends on 12)

The dialysis system of claim 12, wherein the at least one filter is positioned and arranged to filter the mixed dialysis fluid.

### Claim 14 (depends on 12)

The dialysis system of claim 12, wherein the at least one filter includes a first filter configured to remove the particles and a second filter configured to remove the endotoxin.

### Claim 15 (depends on 12)

The dialysis system of claim 12, wherein the dialysis fluid source further includes a first concentrate pump for pumping the first concentrate and a second concentrate pump for pumping the second concentrate.

### Claim 16 (depends on 12)

The dialysis system of claim 12, wherein at least one of the first or second concentrates is provided in powdered or solution form.

### Claim 17

A dialysis system comprising:
a dialysis machine including at least one pump positioned and arranged to pump a dialysis fluid;
a dialysis fluid source located separate from and in fluid communication with the dialysis fluid machine, the dialysis fluid source including
a purified water line for carrying purified water,
a source of a first concentrate,
a source of a second concentrate, and
a controller configured to precisely proportion flows of the purified water, the first concentrate, and the second concentrate to mix the dialysis fluid; and
a flow regulation device located between the dialysis fluid source and the dialysis machine, the flow regulation device including an inlet in fluid communication with the dialysis fluid source, an outlet in fluid communication with the dialysis machine, and a closed volume defined by walls that are configured to expand and contract to provide a variable internal volume,
wherein a cross-sectional width of the variable internal volume of the flow regulation device is larger than diameters of the inlet and the outlet to smooth changes in a draw rate of the dialysis fluid from the dialysis machine.

### Claim 18 (depends on 17)

The dialysis system of claim 17, wherein the dialysis fluid source further includes a first concentrate pump positioned and arranged to pump the first concentrate from the first concentrate source, a second concentrate pump positioned and arranged to pump the second concentrate from the second concentrate source, and wherein the controller is configured to precisely proportion the flows by controlling the first and second concentrate pumps.

### Claim 19 (depends on 17)

The dialysis system of claim 17, wherein the dialysis fluid source further includes at least one conductivity sensor positioned and arranged to monitor mixing of the dialysis fluid.

### Claim 20 (depends on 17)

The dialysis system of claim 17, wherein the controller is configured to communicate with the dialysis machine regarding a dialysis fluid demand of the dialysis machine.
