Filtration system for preparation of fluids for medical applications

Patent metadata

Field	Value
Publication number	US-11633527-B2
Application number	US-202016889930-A
Country	US
Kind code	B2
Filing date	Jun 2, 2020
Priority date	Apr 7, 2006
Publication date	Apr 25, 2023
Grant date	Apr 25, 2023

Abstract

A system for filling multiple sterile containers includes a filter with an inlet port and multiple outlet ports, the outlet ports being pre-attached to sterile containers by respective filling lines of each container. Each container has an interior and each of the respective filling lines are connected to a respective container interior. The respective filling lines are sealed to the outlet ports and the containers such that the container interiors are isolated from an external environment except the inlet port, via the filter, forming a combined interior volume which is sterile. A container that is connectable to an outlet port the system has a bladder, a first tube and a second tube connected to the bladder, and a sterilizing filter. The container, the first tube and the second tube, and the sterilizing filter are sterile before water is flowed through the sterilizing filter into the bladder.

First claim

The invention claimed is:

1. A container system that is connectable to an outlet port of a medicament filling system, the container system comprising:
a fluid container;
at least a first tube fluidly connected to the fluid container through a first bag connection and a second tube fluidly connected to the fluid container through a second bag connection that is distinct from the first bag connection;
a sterilizing filter with a filter inlet port and a filter outlet port, the filter outlet port fluidly connected to the first tube and the second tube, and the filter inlet port fluidly connected to a fluid supply line that supplies water to the container system;
a first connector terminating the fluid supply line;
a first removable seal closing the first connector; and
a third tube fluidly connected to the fluid container, wherein
the fluid container, the first tube and the second tube, and the sterilizing filter are sterile before water is flowed through the sterilizing filter into the fluid container.

2. The container system according to claim 1 , wherein the sterilizing filter is a 0.22 micro pore filter or a pyrogen filter.

3. The container system according to claim 1 , further comprising:
a manifold that splits fluid flow into at least two branches, wherein
the manifold is fluidly connected to the first tube.

4. The container system according to claim 1 , further comprising:
a quantity of a concentrated medicament in the fluid container.

5. The container system according to claim 4 , wherein
the fluid container and the concentrated medicament are sterile before the first removable seal is opened.

6. The container system according to claim 1 , further comprising:
a data carrier affixed to the fluid container, the data carrier storing data indicating properties of a concentrated medicament that has been injected into the fluid container.

7. The container system according to claim 1 , further comprising:
a second sterilizing filter fluidly connected to the third tube to sterile filter concentrated medicament flowing into the fluid container.

8. The container system according to claim 1 , wherein
the second tube includes an extension inside of the fluid container, the extension being a tube that is free to move when a fluid is pumped through the second tube into the fluid container.

9. The container system according to claim 3 , wherein
the manifold is a Y-connector with four stems,
a first stem is connected to the first tube,
a second, a third, and a fourth stem are connected to connectors configured to connect to a dialysis cycler.

10. A container system,
that is connectable to an outlet port of a medicament filling system, the container system comprising:
a fluid container;
at least a first tube and a second tube fluidly connected to the fluid container;
a sterilizing filter with a filter inlet port and a filter outlet port, the filter outlet port fluidly connected to the first tube and the second tube, and the filter inlet port fluidly connected to a fluid supply line that supplies water to the container system;
a first connector terminating the fluid supply line;
a first removable seal closing the first connector; and
a third tube fluidly connected to the fluid container; and
a manifold that splits fluid flow into at least two branches, wherein
the fluid container, the first tube and the second tube, and the sterilizing filter are sterile before water is flowed through the sterilizing filter into the fluid container,
the manifold is fluidly connected to the first tube,
the manifold is a Y-connector with four stems,
a first stem is connected to the first tube, and
a second, a third, and a fourth stem are connected to connectors configured to connect to a dialysis cycler.

11. The container system according to claim 10 , wherein the sterilizing filter has a pore size of less than 0.1 micron.

12. The container system according to claim 10 , further comprising:
a quantity of a concentrated medicament in the fluid container.

13. The container system according to claim 12 , wherein
the fluid container and the concentrated medicament are sterile before the first removable seal is opened.

14. The container system according to claim 10 , further comprising:
a data carrier affixed to the fluid container, the data carrier storing data indicating properties of a concentrated medicament that has been injected into the fluid container.

15. The container system according to claim 10 , further comprising:
a second sterilizing filter fluidly connected to the third tube to sterile filter concentrated medicament flowing into the fluid container.

16. A container system, that is connectable to an outlet port of a medicament filling system, the container system comprising:
a fluid container;
at least a first tube and a second tube fluidly connected to the fluid container;
a sterilizing filter with a filter inlet port and a filter outlet port, the filter outlet port fluidly connected to the first tube and the second tube, and the filter inlet port fluidly connected to a fluid supply line that supplies water to the container system;
a first connector terminating the fluid supply line;
a first removable seal closing the first connector; and
a third tube fluidly connected to the fluid container, wherein
the fluid container, the first tube and the second tube, and the sterilizing filter are sterile before water is flowed through the sterilizing filter into the fluid container, wherein
the second tube includes an extension inside of the fluid container, the extension being a tube that is free to move when a fluid is pumped through the second tube into the fluid container.

17. The container system according to claim 16 , wherein the sterilizing filter has a pore size of less than 0.1 micron.

18. The container system according to claim 16 , further comprising:
a quantity of a concentrated medicament in the fluid container.

19. The container system according to claim 18 , wherein
the fluid container and the concentrated medicament are sterile before the first removable seal is opened.

20. The container system according to claim 16 , further comprising:
a second sterilizing filter fluidly connected to the third tube to sterile filter concentrated medicament flowing into the fluid container.

Assignees

• Nxstage Medical Inc

Inventors

• Burbank Jeffrey H
• Brugger James M

Classifications

• B01D61/146

  comprising multiple ultrafiltration steps · CPC title

• F16K7/068

  by bending the hose · CPC title

• A61M1/167

  Flexible packaging for solid concentrates · CPC title

• C02F1/444

  by ultrafiltration or microfiltration · CPC title

• A61M1/1656

  Apparatus for preparing dialysates · CPC title