Fluid preparation and treatment devices methods and systems

Patent metadata

Field	Value
Publication number	US-11364328-B2
Application number	US-201916288568-A
Country	US
Kind code	B2
Filing date	Feb 28, 2019
Priority date	Feb 28, 2018
Publication date	Jun 21, 2022
Grant date	Jun 21, 2022

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 method for making a peritoneal dialysis fluid, comprising:
connecting a first fluid circuit to a proportioning machine, the first fluid circuit including a mixing container integrally attached to the first fluid circuit and that is empty before the connecting, a water inlet connector, two or more concentrate inlet connectors, and empty low-capacity concentrate containers, the proportioning machine having actuators that engage with the first fluid circuit when received thereby;
connecting a water source to the water inlet connector of the first fluid circuit;
connecting two or more containers of concentrate to the two or more concentrate inlet connectors of the first fluid circuit, each of said two or more containers of concentrate having sufficient concentrate for making the peritoneal dialysis fluid for multiple peritoneal dialysis treatments, where one peritoneal dialysis treatment includes one or more fill cycles that fill a peritoneal cavity with the peritoneal dialysis fluid and corresponding drain cycles that drain the peritoneal dialysis fluid from the peritoneal cavity;
filling the empty low-capacity concentrate containers included in the first fluid circuit with concentrate from the two or more containers of concentrate;
using a controller of the proportioning machine, flowing purified water from the water source through the water inlet connector and concentrate from the two or more containers of concentrate through the two or more concentrate inlet connectors and through the first fluid circuit to the mixing container of the first fluid circuit to prepare the peritoneal dialysis fluid in said mixing container by proportioning the purified water and the concentrate, wherein the flowing includes flowing the purified water and the concentrate through at least one sterilizing filter to ensure sterility of the purified water and the concentrate;
using the controller, performing a peritoneal dialysis treatment on a patient using the peritoneal dialysis fluid from said mixing container, said peritoneal dialysis treatment including multiple fill cycles and corresponding drain cycles;
after performing the peritoneal dialysis treatment, replacing the first fluid circuit with a second fluid circuit that is identical to the first fluid circuit and includes its own mixing container, water inlet connector, and two or more concentrate inlet connectors, the replacing including
disconnecting the first fluid circuit from the proportioning machine,
disconnecting the water inlet connector of the first fluid circuit from the water source, and
disconnecting the two or more concentrate inlet connectors of the first fluid circuit from the two or more containers of concentrate;
connecting the second fluid circuit to the proportioning machine,
connecting the water inlet connector of the second fluid circuit to the water source, and
connecting the two or more concentrate inlet connectors of the second fluid circuit to the two or more containers of concentrate;

after the replacing, using the controller of the proportioning machine, flowing the purified water through the water inlet connector of the second fluid circuit and the concentrate from the two or more containers of concentrate through the two or more concentrate inlet connectors of the second fluid circuit and through the second fluid circuit to the mixing container of the second fluid circuit to prepare a second batch of the peritoneal dialysis fluid in the mixing container of the second fluid circuit; and
treating the patient using the second batch of the peritoneal dialysis fluid from the mixing container of the second fluid circuit, without replacing said two or more containers of concentrate, whereby the two or more containers of concentrate are replaced once for every multiple replacements of fluid circuits.

2. The method of claim 1 , wherein
said at least one sterilizing filter is integrally attached to said first fluid circuit.

3. The method of claim 2 , wherein
said flowing the purified water and the concentrate through at least one sterilizing filter includes flowing the purified water and the concentrate through separate filters.

4. The method of claim 1 , wherein the flowing the purified water includes pumping said purified water by a pump of the water source.

5. A treatment method, comprising:
connecting a fluid circuit to a proportioning machine, the fluid circuit including an integrally attached mixing container that is empty before the connecting, empty low-capacity concentrate containers, and one or more concentrate inlet connectors, the proportioning machine having actuators that engage with the fluid circuit when received thereby;
connecting one or more containers of medicament concentrate through the one or more concentrate inlet connectors to the fluid circuit, each container of the one or more containers having sufficient medicament concentrate to generate a medicament for multiple treatments of a patient, where one treatment includes one or more fill cycles that fill a peritoneal cavity with the medicament and corresponding drain cycles that drain the medicament from the peritoneal cavity;
filling the empty low-capacity concentrate containers included in the fluid circuit with medicament concentrate from the one or more containers of medicament concentrate;
using the proportioning machine, flowing purified water and flowing the medicament concentrate through the one or more concentrate inlet connectors and through the fluid circuit to the mixing container to prepare the medicament in the mixing container by proportioning the purified water and the medicament concentrate, the flowing including flowing the purified water and the medicament concentrate through at least one sterilizing filter to ensure sterility of the purified water and of the medicament concentrate;
ensuring an integrity of the at least one sterilizing filter by testing the at least one sterilizing filter or providing serially-connected redundant sterilizing filters;
treating the patient using the medicament prepared in the mixing container; and
replacing the fluid circuit with a new fluid circuit that is identical to the fluid circuit and includes its own mixing container and repeating the connecting with the new fluid circuit, flowing the purified water and the medicament concentrate, treating the patient using the new fluid circuit, without replacing said one or more containers of medicament concentrate.

6. The method of claim 5 , wherein said at least one sterilizing filter is integrally attached to said fluid circuit.

7. The method of claim 5 , wherein said flowing the purified water and the medicament concentrate through at least one sterilizing filter includes flowing the purified water and the medicament concentrate through separate filters.

8. The method according to claim 1 , wherein
the at least one sterilizing filter includes serially-connected redundant sterilizing filters.

9. The method according to claim 1 , further comprising:
using said controller, testing integrity of a membrane of the at least one sterilizing filter; and
preventing a use of contents of the mixing container of the first fluid circuit responsively to a result indicating failure of the integrity of the membrane.

10. The method according to claim 1 , further comprising:
pumping the concentrate from the low-capacity concentrate containers that were filled by the filling, with a peristaltic pump, to a conductivity sensor in fluid communication with a drain line of the first fluid circuit.

11. The method according to claim 5 , further comprising:
pumping the concentrate from the low-capacity concentrate containers that were filled by t

Assignees

• Nxstage Medical Inc

Inventors

• Wyeth Mark T
• Yantz Gregory

Classifications

• C02F1/32

  with ultraviolet light · CPC title

• A61M2205/215

  Tilt detection, e.g. for warning or shut-off · CPC title

• A61M1/1666

  by dissolving solids · CPC title

• C02F1/42

  by ion-exchange (ion-exchange in general B01J) · CPC title

• A61M1/287 Primary

  Dialysates therefor · CPC title