# US 11,433,170 B2 · Dialysis systems, devices, and methods

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- Number: US 11,433,170 B2
- Document ID: US11433170B2
- Status: Granted
- Kind: B2
- Application number: 17/403,614
- Filed: 2021-08-16
- Published: 2021-12-09
- Granted: 2022-09-06
- Earliest claimed: 2011-03-23
- Assignees: NxStage Medical, Inc.
- Applicants: NxStage Medical, Inc.
- Inventors: Jeffrey H. Burbank; James M. Brugger; Dennis M. Treu; Mark T. Wyeth
- Web page: https://patentgrep.com/patent/US11433170B2

## CPC

- A61M 1/282: {Operational modes}
- A61M 1/1524: {the interface providing means for actuating on functional elements of the cassette, e.g. plungers}
- A61M 1/154: {with sensing means or components thereof}
- A61M 1/155: {with treatment-fluid pumping means or components thereof}
- A61M 1/1562: {Details of incorporated reservoirs}
- A61M 1/1565: {Details of valves}
- A61M 1/159: {specially adapted for peritoneal dialysis}
- A61M 1/1656: {Apparatus for preparing dialysates}
- A61M 1/166: {Heating (for sterilisation A61M1/1686)}
- A61M 1/1664: {with temperature control}
- A61M 1/1668: {Details of containers}
- A61M 1/167: {Flexible packaging for solid concentrates}
- A61M 1/1672: {using membrane filters, e.g. for sterilising the dialysate}
- A61M 1/1674: {using UV radiation sources for sterilising the dialysate}
- A61M 1/28: Peritoneal dialysis {; Other peritoneal treatment, e.g. oxygenation}
- A61M 1/281: {Instillation other than by gravity}
- A61M 1/285: {Catheters therefor}
- A61M 1/287: {Dialysates therefor}
- A61M 1/288: {Priming (priming in extracorporeal blood circuits A61M1/3643)}
- A61M 2025/0002: {with a pressure sensor at the distal end}
- A61M 2205/12: with interchangeable cassettes forming partially or totally the fluid circuit
- A61M 2205/123: with incorporated reservoirs
- A61M 2205/128: with incorporated valves
- A61M 2205/14: Detection of the presence or absence of a tube, a connector or a container in an apparatus
- A61M 2205/18: with alarm
- A61M 2205/33: Controlling, regulating or measuring
- A61M 2205/3331: Pressure; Flow
- A61M 2205/3334: Measuring or controlling the flow rate
- A61M 2205/3351: Controlling upstream pump pressure
- A61M 2205/3355: Controlling downstream pump pressure
- A61M 2205/52: with memories providing a history of measured variating parameters of apparatus or patient
- A61M 2230/005: Parameter used as control input for the apparatus
- 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 treatment device system includes a treatment machine for generating a custom dialysis solution and including at least one fluid conveyor, the treatment machine having a controller, the controller having a first memory, configured to produce the custom dialysis solution by causing the at least one fluid conveyor to mix purified water and at least one concentrate. The system also includes a user interface and a water purifier in fluid communication with and providing the purified water to the treatment machine, the water purifier including an internal central controller, the internal central controller having a second memory, to control preparation of the purified water. A server is communicatively coupled with the treatment machine and a control line provides two way communication between the controller of the treatment machine and the internal central controller of the water purifier.

## Claims

### Claim 1

A treatment device system, comprising:
a treatment machine for generating a custom dialysis solution and including at least one fluid conveyor, the treatment machine comprising a controller, the controller comprising a first memory, the treatment machine configured to produce the custom dialysis solution by causing the at least one fluid conveyor to mix purified water and at least one concentrate;
a user interface operably connected to the treatment machine, the user interface configured to receive operator inputs;
a water purifier in fluid communication with and providing the purified water to the treatment machine, the water purifier including an internal central controller to control preparation of the purified water, the internal central controller comprising a second memory;
a server communicatively coupled with the treatment machine; and
a wired or wireless control line providing two way communication between the controller of the treatment machine and the internal central controller of the water purifier, wherein the controller of the treatment machine transmits data via the control line to the internal central controller of the water purifier, the data provided based on a prescription sent from the server to the treatment machine.

### Claim 2 (depends on 1)

The treatment device system of claim 1, wherein the prescription specifies a control signal for control of the water purifier.

### Claim 3 (depends on 1)

The treatment device system of claim 1, wherein the prescription specifies control signals transmitted from the treatment machine to the water purifier.

### Claim 4 (depends on 1)

The treatment device system of claim 1, wherein the prescription specifies a command for the treatment machine, the data provided based on the specified command.

### Claim 5 (depends on 4)

The treatment device system of claim 4, wherein the treatment machine determines the data provided based on the specified command.

### Claim 6 (depends on 4)

The treatment device system of claim 4, wherein the water purifier uses the data to determine an operating parameter for the water purifier.

### Claim 7 (depends on 1)

The treatment device system of claim 1, wherein the server is configured to send a software upgrade to the treatment machine, the software upgrade, if meant for the water purifier, forwarded by the treatment machine to the water purifier.

### Claim 8 (depends on 1)

The treatment device system of claim 1, wherein a software upgrade is automatically installed on the water purifier or installed upon acceptance by a user via the user interface.

### Claim 9 (depends on 1)

The treatment device system of claim 1, wherein the server is in data communication with a service computer, the service computer enabling a service person to access the water purifier via the control line with the treatment machine to perform at least one service procedure.

### Claim 10 (depends on 1)

The treatment device system of claim 1, wherein upon startup, the treatment machine is configured to determine if the water purifier is in a hibernation mode and, if so, to perform a startup procedure not involving the water purifier.

### Claim 11 (depends on 1)

The treatment device system of claim 1, which is configured to run at least one self-testing procedure for the treatment machine and at least one self-testing procedure for the water purifier.

### Claim 12 (depends on 1)

The treatment device system of claim 1, wherein the water purifier includes a user interface in communication with the internal central controller of the water purifier, and wherein the user interface of the water purifier operates the water purifier if the wired or wireless control line between the controller of the treatment machine and the internal central controller of the water purifier is broken.

### Claim 13

A treatment device system, comprising:
a treatment machine for generating a custom dialysis solution and including at least one fluid conveyor, the treatment machine comprising a controller, the controller comprising a first memory, the treatment machine configured to produce the custom dialysis solution by causing the at least one fluid conveyor to mix purified water and at least one concentrate;
a user interface operably connected to the treatment machine, the user interface configured to receive operator inputs;
a water purifier in fluid communication with and providing the purified water to the treatment machine, the water purifier including an internal central controller to control preparation of the purified water, the internal central controller comprising a second memory;
a server communicatively coupled with the treatment machine; and
a wired or wireless control line providing two way communication between the controller of the treatment machine and the internal central controller of the water purifier, wherein the internal central controller of the water purifier transmits sensor signals via the control line to the controller of the treatment machine, wherein the controller of the treatment machine forwards data related to the sensor signals to the server.

### Claim 14 (depends on 13)

The treatment device system of claim 13, wherein the transmitted sensor signals include patient-specific treatment data.

### Claim 15 (depends on 13)

The treatment device system of claim 13, wherein the transmitted sensor signals include expiration data.

### Claim 16 (depends on 13)

The treatment device system of claim 13, wherein the water purifier includes a user interface in communication with the internal central controller of the water purifier, wherein the user interface of the treatment machine operates both the treatment machine and the water purifier if the control line between the controller of the treatment machine and the internal central controller of the water purifier is maintained, and wherein the user interface of the water purifier operates the water purifier if the wired or wireless control line is broken.
