Batch filtration system for preparation of sterile fluid for renal replacement therapy

• US 8,460,558 B2
• Filed: 06/18/2012
• Issued: 06/11/2013
• Est. Priority Date: 01/07/2003
• Status: Expired due to Term

• Current Assignee: Nxstage Medical Incorporated (Fresenius Medical Care AG)
• Original Assignee: Nxstage Medical Incorporated (Fresenius Medical Care AG)
• Inventors: Brugger, James M., Burbank, Jeffrey H., Green, Brian C.
• Primary Examiner(s): Kim, John
• Application Number:
  US13/526,145
• Publication Number:
  US 20120305481A1
• Time in Patent Office: 358 Days
• Field of Search: 210/85, 210/87, 210/90, 210/97, 210/109, 210/134, 210/143, 210/645, 210/646, 210/739, 210/767, 604/6.09, 604/6.11, 604/6.13, 604/9, 604/28, 604/29, 604/30
• US Class Current: 210/767
• CPC Class Codes: A61M 1/14 Dialysis systems; Artificial kidneys; Blood oxygenators semi-permeable membranes characterised by the material, manufacturing processes therefor B01D71/00 ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
• CPC Class Codes: A61M 1/1656 Apparatus for preparing dialysates
• CPC Class Codes: A61M 1/166 Heating for sterilisation A61M1/1686
• CPC Class Codes: A61M 1/167 Flexible packaging for solid concentrates
• CPC Class Codes: A61M 1/1672 using membrane filters, e.g. for sterilising the dialysate
• CPC Class Codes: A61M 1/1674 using UV radiation sources for sterilising the dialysate
• CPC Class Codes: A61M 1/28 Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
• CPC Class Codes: A61M 1/288 Priming priming in extracorporeal blood circuits A61M1/3643
• CPC Class Codes: A61M 1/3462 Circuits for the preparation thereof
• CPC Class Codes: A61M 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: C02F 1/44 by dialysis, osmosis or reverse osmosis general membrane separation processes B01D61/00, membrane modules B01D63/00, electrodialysis C02F1/4693, combination of membrane modules and bioreactors C02F3/1268

Abstract

A first connector of a connector assembly of a sterile batch container can be unsealed. The connector assembly can be attached to a filling port of the sterile batch container and can have a sterile filter arranged between the filling port and the first connector. The first connector can be coupled so as to receive produced purified water. A transmembrane pressure can be monitored across the sterile filter while flowing the purified water through the connector assembly into the sterile batch container so as to provide a sterile fluid stored therein. The connector assembly can be detached from the filling port of the sterile batch container. After the detaching, the sterile batch container can be coupled to the blood treatment system. In response to a change in the transmembrane pressure exceeding a predefined level, an alarm signal can be generated.

Claims

1. A method of providing fluid to a blood treatment system for performing a blood treatment, the method comprising:

at least one of carbon-filtering, deionizing, and ultra-filtering water to produce purified water;

unsealing a first connector of a connector assembly of a sterile batch container, the connector assembly being attached to a filling port of the sterile batch container and having a sterile filter arranged between the filling port and the first connector;

coupling the first connector so as to receive the produced purified water;

monitoring a transmembrane pressure across the sterile filter while flowing the purified water through the connector assembly into the sterile batch container so as to provide a sterile fluid stored therein;

detaching the connector assembly from the filling port of the sterile batch container;

after said detaching, coupling the sterile batch container to the blood treatment system;

flowing the sterile fluid from the sterile batch container to the blood treatment system; and

in response to a change in the transmembrane pressure exceeding a predefined level, generating an alarm signal.

2. The method of claim 1, wherein the at least one of carbon-filtering, deionizing, and ultra-filtering water and the flowing the sterile fluid to the blood treatment system occur at a same treatment location as the blood treatment.

3. The method of claim 1, wherein the sterile batch container has a concentrate solution therein and the flowing the purified water into the sterile batch container includes diluting the concentrate solution to form sterile dialysate.

4. The method of claim 1, wherein the sterile filter is inline with the connector assembly and is effective to isolate contents of the sterile batch container from ingress of contaminants.

5. The method of claim 1, wherein the detaching the connector assembly includes:

leaving the connector assembly coupled so as to receive the produced purified water for an interval of time and to isolate the supply of purified water from contamination during said interval; and

after said interval, detaching the connector assembly and immediately coupling a first connector of a connector assembly of another sterile batch container so as to receive the produced purified water.

6. The method of claim 1, wherein the blood treatment is a renal replacement therapy for a patient and the blood treatment system is one of a hemofiltration machine, a hemodiafiltration machine, and a hemodialysis machine.