# US 11,110,213 B2 · Mixing for online medical fluid generation

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- Number: US 11,110,213 B2
- Document ID: US11110213B2
- Status: Granted
- Kind: B2
- Application number: 16/175,355
- Filed: 2018-10-30
- Published: 2019-05-02
- Granted: 2021-09-07
- Earliest claimed: 2017-11-01
- Assignees: Gambro Lundia AB
- Applicants: Baxter International Inc.; Baxter Healthcare S.A.
- Inventors: Olof Jansson; Anders J. Wellings
- Web page: https://patentgrep.com/patent/US11110213B2

## CPC

- A61M 1/1656: {Apparatus for preparing dialysates}
- A61M 1/152: {Details related to the interface between cassette and machine}
- A61M 1/155: {with treatment-fluid pumping means or components thereof}
- A61M 1/1561: {at least one cassette surface or portion thereof being flexible, e.g. the cassette having a rigid base portion with preformed channels and being covered with a foil}
- A61M 1/1565: {Details of valves}
- A61M 1/159: {specially adapted for peritoneal dialysis}
- A61M 1/1621: {Constructional aspects thereof (semi-permeable membranes for separation processes characterised by their properties B01D69/00; semi permeable membranes characterised by their material B01D71/00)}
- A61M 1/1668: {Details of containers}
- A61M 1/1694: {with recirculating dialysing liquid}
- A61M 1/28: Peritoneal dialysis {; Other peritoneal treatment, e.g. oxygenation}
- A61M 1/287: {Dialysates therefor}
- A61M 1/3635: {Constructional details}
- B01D 61/243: {Dialysis}
- A61M 1/1562: {Details of incorporated reservoirs}
- A61M 2205/12: with interchangeable cassettes forming partially or totally the fluid circuit
- A61M 2205/123: with incorporated reservoirs
- A61M 2205/3334: Measuring or controlling the flow rate
- 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)}
- B01D: SEPARATION (separating solids from solids by wet methods B03B, B03D; by pneumatic jigs or tables B03B; by other dry methods B07; magnetic or electrostatic separation of solid materials from solid materials or fluids, separation by high-voltage electric fields B03C; centrifuges, vortex apparatus B04; presses per se for squeezing-out liquid from liquid-containing material B30B9/02; treatment of water C02F, e.g. softening by ion-exchange C02F1/42; {arrangements of air intake cleaners in gas turbine plants F02C7/05} ; arrangements or mounting of filters in air-conditioning, air-humidification or ventilation F24F13/28)

## Abstract

A dialysis system includes: (i) a source of water made suitable for a dialysis treatment; (ii) at least one concentrate for mixing with the water from the source; (iii) a dialysis fluid pump; and (iv) a disposable set operable with the dialysis fluid pump and in fluid communication with the source of water and the at least one concentrate, the disposable set including a container having a first end and a second end, the container configured to allow the water and the at least one concentrate pumped by the dialysis fluid pump to enter at the second end and exit from the first end to mix for the dialysis treatment.

## Claims

### Claim 1

A dialysis system comprising:
a source of water made suitable for a dialysis treatment;
at least one concentrate for mixing with the water from the source;
a dialysis fluid pump; and
a disposable set operable with the dialysis fluid pump and in fluid communication with the source of water and the at least one concentrate, the disposable set including a container having a first proximal end and a second distal end, the container configured such that the water and the at least one concentrate pumped by the dialysis fluid pump enters at the second distal end and exits from the first proximal end, via a passageway extending from the first proximal end to the second distal end, to mix for the dialysis treatment,
wherein the first proximal end includes a connector, the connector defining at least one groove positioned and arranged on an outer surface of the connector,
the at least one groove is configured to allow the water and the at least one concentrate, which are at least partially mixed together, to travel through the at least one groove formed between the connector and the container to a port of the container, and
the connector is associated with at least one one-way valve configured to prevent the water and the at least one concentrate from flowing from an inside of the container and back through the passageway towards the first proximal end.

### Claim 2 (depends on 1)

The dialysis system of claim 1, which is configured such that the water and the at least one concentrate pumped by the dialysis fluid pump enter the container partially mixed together.

### Claim 3 (depends on 1)

The dialysis system of claim 1, wherein the container is a flexible bag formed from flexible sheets, and wherein the flexible sheets include a first flexible sheet and a second flexible sheet.

### Claim 4 (depends on 1)

The dialysis system of claim 1, wherein the disposable set includes a pumping cassette that interfaces with the dialysis fluid pump.

### Claim 5 (depends on 4)

The dialysis system of claim 4, wherein the water and the at least one concentrate are mixed initially in the pumping cassette.

### Claim 6 (depends on 4)

The dialysis system of claim 4, wherein the dialysis fluid pump pneumatically actuates the pumping cassette.

### Claim 7 (depends on 4)

The dialysis system of claim 4, wherein the disposable set includes a tube extending from the pumping cassette to the container.

### Claim 8 (depends on 7)

The dialysis system of claim 7, wherein the tube is a first tube and wherein the disposable set includes at least one second tube extending from the pumping cassette to the at least one concentrate.

### Claim 9 (depends on 7)

The dialysis system of claim 7, wherein the tube is a first tube and wherein the disposable set includes a second tube extending from the pumping cassette to an accumulator that receives the water made suitable for the dialysis treatment from the source.

### Claim 10 (depends on 4)

The dialysis system of claim 4, which is configured to pump the water and the at least one concentrate back and forth from the pumping cassette to the container a plurality of times to perform a mixing sequence for further mixing.

### Claim 11 (depends on 1)

The dialysis system of claim 1, wherein the passageway is a tube extending within the container from the port to the second distal end of the container.

### Claim 12 (depends on 11)

The dialysis system of claim 11, which is configured to deliver the water and the at least one concentrate into the container via the tube at the second distal end and remove further mixed water and at least one concentrate from the container via the connector at the first proximal end.

### Claim 13 (depends on 1)

The dialysis system of claim 1, wherein the container is sealed so as to form a passageway leading to the second distal end of the container.

### Claim 14 (depends on 1)

The dialysis system of claim 1, wherein the port is formed as part of the connector.

### Claim 15 (depends on 1)

The dialysis system of claim 1, wherein the container is sealed so as to form the passageway leading to the second distal end of the container, and wherein the passageway extends from and fluidly communicates with an aperture defined by the connector.

### Claim 16 (depends on 15)

The dialysis system of claim 15, wherein the aperture is a first aperture and which includes a second aperture defined by the connector, the second aperture allowing the water and the at least one concentrate at least partially mixed for the dialysis treatment to exit the container.

### Claim 17 (depends on 16)

The dialysis system of claim 16, wherein the at least one one-way valve is a first one-way valve, and wherein the second aperture is fitted with or located adjacent to the first one-way valve.

### Claim 18 (depends on 13)

The dialysis system of claim 13, wherein the passageway is structured to collapse under negative pressure.

### Claim 19

A dialysis system comprising:
a source of water made suitable for a dialysis treatment;
at least one concentrate for mixing with the water from the source; and
a disposable set in fluid communication with the source of water and the at least one concentrate, the disposable set including a container having a first proximal end and a second distal end, the container including (i) a tube structured and arranged within the container, the tube extending from the first proximal end to the second distal end such that the water and the at least one concentrate to flow through the tube and enter the container at the second distal end and (ii) a port at the first proximal end, the port associated with at least one one-way valve such that the water and the at least one concentrate at least partially mixed for the dialysis treatment exit the first proximal end of container while the at least one one-way valve prevents the water and the at least one concentrate from traveling back through the tube towards the first proximal end, wherein the first proximal end of the container includes a connector, the port forming part of the connector, and wherein the connector is placed in fluid communication with the tube.

### Claim 20 (depends on 19)

The dialysis system of claim 19, wherein the tube and the port connect at a junction outside of the container.

### Claim 21 (depends on 19)

The dialysis system of claim 19, wherein the at least one one-way valve is a first one-way valve, and wherein at least one of the tube and the port is fitted with the first one-way valve.

### Claim 22

A dialysis system comprising:
a source of water made suitable for a dialysis treatment;
at least one concentrate for mixing with the water from the source; and
a disposable set in fluid communication with the source of water and the at least one concentrate, the disposable set including a container having at least one outer seal forming a first proximal end and a second distal end, the container sealed within the at least one outer seal so as to form a passageway leading to the second distal end of the container, the container further including a port at the first proximal end, the port associated with at least one one-way valve, wherein
the passageway is structured and arranged such that the water and the at least one concentrate enter the passageway, from the port at the first proximal end, and flow, according to the at least one one-way valve, through the passageway to enter the container at the second distal end, and
the port is structured and arranged such that the water and the at least one concentrate that have at least partially mixed for the dialysis treatment to exit the first proximal end of the container while the at least one one-way valve prevents the water and the at least one concentrate from traveling back through the passageway.

### Claim 23 (depends on 22)

The dialysis system of claim 22, wherein the first end of the container includes a connector, the connector defining at least one groove positioned and arranged to allow the water and the at least one concentrate that have at least partially mixed within the container for dialysis treatment to travel through the at least one groove to the port to exit the container.

### Claim 24 (depends on 23)

The dialysis system of claim 23, wherein the port is formed as part of the connector.

### Claim 25 (depends on 24)

The dialysis system of claim 24, wherein the passageway extends from and fluidly communicates with an aperture defined by the connector.

### Claim 26 (depends on 25)

The dialysis system of claim 25, wherein the aperture is a first aperture and which includes a second aperture defined by the connector, the second aperture allowing the water and the at least one concentrate at least partially mixed for the dialysis treatment to exit the container.

### Claim 27 (depends on 26)

The dialysis system of claim 26, wherein the at least one one-way valve is a first one-way valve, and wherein the second aperture is fitted with or adjacent to the first one-way valve.

### Claim 28 (depends on 22)

The dialysis system of claim 22, wherein the passageway is structured to collapse under negative pressure.
