Fluid preparation and treatment devices methods and systems

Patent metadata

Field	Value
Publication number	US-12409259-B2
Application number	US-202318536637-A
Country	US
Kind code	B2
Filing date	Dec 12, 2023
Priority date	Feb 28, 2018
Publication date	Sep 9, 2025
Grant date	Sep 9, 2025

Abstract

Methods, device, and systems for preparing peritoneal dialysis fluid and/or administering a peritoneal dialysis treatment are disclosed. In embodiments, peritoneal dialysis fluid is prepared at a point of use automatically using a daily sterile disposable fluid circuit and one or more long-term concentrate containers that are changed only after multiple days (e.g. weekly). The daily disposable may have concentrate containers that are initially empty and are filled from the long-term concentrate containers once per day at the beginning of a treatment.

First claim

What is claimed is:

1. A system for preparation of a sterile medical treatment fluid, comprising:
at least one fluid circuit with a pumping tube segment and multiple valve segments;
at least one pumping actuator configured to engage the pumping tube segment;
multiple valve actuators configured to engage said multiple valve segments;
a controller configured to control said multiple valve actuators and said at least one pumping actuator;
a first of the multiple valve segments being along a fluid inlet line with a sterilizing filter;
a first multi-treatment concentrate container having a quantity of a first concentrate that is sufficient for preparation of enough peritoneal dialysis fluid to perform multiple peritoneal dialysis treatments, each of the multiple peritoneal dialysis treatments including multiple fill/drain cycles;
a water source;
the at least one fluid circuit having, integrally-attached thereto, a first single-treatment concentrate container and a mixing container, the mixing container being sized to hold sufficient peritoneal dialysis fluid for at least a single fill cycle and the first single-treatment concentrate container being empty when the at least one fluid circuit is initially connected to the first multi-treatment concentrate container;
ones of said multiple valve segments connected between said fluid inlet line and said water source and between said first multi-treatment concentrate container and said fluid inlet line, wherein
the controller is configured to control said ones of said multiple valve actuators and said at least one pumping actuator, to sequentially connect the first single-treatment concentrate container and the water source to the fluid inlet line and to control flow through the fluid inlet line such that water is conveyed from the water source to the mixing container and some of the first concentrate is conveyed from the first multi-treatment concentrate container to the first single-treatment concentrate container, and subsequently to pump the first concentrate from the first single-treatment concentrate container to the mixing container so that the first concentrate is incorporated in a dialysis fluid formed in the mixing container.

2. The system of claim 1 , wherein the controller is configured to perform a fill/drain cycle including draining spent fluid from a patient line and pumping the dialysis fluid from the mixing container to the patient line.

3. The system of claim 1 , further comprising a second multi-treatment concentrate container that contains a second concentrate, wherein, ones of said multiple valve segments are connected to said second multi-treatment concentrate container and said fluid inlet line.

4. The system of claim 3 , further comprising:
a second single-treatment concentrate container connected to said fluid circuit that is initially empty when the at least one fluid circuit is initially connected to the second multi-treatment concentrate container, wherein
said controller is configured to control said ones of said multiple valve actuators and said at least one pumping actuator to transfer some of the second concentrate from the second multi-treatment concentrate container to the second single-treatment concentrate container, and to subsequently transfer the second concentrate from the second single-treatment concentrate container to the mixing container to form said dialysis fluid.

5. The system of claim 3 , wherein the sterilizing filter has an air port to allow a membrane of the sterilizing filter to be pressure tested, the controller being programmed to test the membrane by applying pressure to the air port and measuring the pressure after pumping water therethrough.

6. The system of claim 5 , wherein the controller is configured to generate an alarm signal responsively to a result of a test of said membrane if said test indicates a loss of integrity of said membrane.

Assignees

• Nxstage Medical Inc

Inventors

• Wyeth Mark T
• Yantz Gregory
• De La Vega Ciro A

Classifications

• A61M2205/05

  combined with other kinds of therapy · CPC title

• A61M1/155

  with treatment-fluid pumping means or components thereof · CPC title

• A61M1/1565

  Details of valves · CPC title

• A61M1/156

  Constructional details of the cassette, e.g. specific details on material or shape · CPC title

• A61M1/159

  specially adapted for peritoneal dialysis · CPC title